Searching for keyword:"Healthy Volunteers"

2,318 results
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US Clinical Trial NCT00972179 – NIH – Sep 3, 2009

A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 157 in Healthy Subjects

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US Clinical Trial NCT01545765 – NIH – Feb 24, 2012

Anesthetic Effect Duration Produced by Lidocaine 7% + Tetracaine 7% Cream on 2 Different Body Areas

Subjects will have 4 target zones defined; 2 on the face and 2 on the anterior thighs. Upon inclusion into the study, subjects will have the study drug applied with a different application time to one side of the face and anterior thigh according to...
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US Clinical Trial NCT02637284 – NIH – Dec 15, 2015

Phase I, Pilot Study in Healthy Volunteers, to Assess the Safety and Pharmacokinetics of PCO-02, Which Active Ingredient is BPC-157, a Penta-deca-peptide From Gastric Source.

Title: Phase I, pilot study in healthy volunteers, to assess the safety and pharmacokinetics of PCO-02, which active ingredient is BPC-157, a pentadecapeptide from gastric source. Protocol Number: BPC-1A/B-1.2 Phase: I Population: Healthy subject...
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US Clinical Trial NCT02218346 – NIH – Aug 13, 2014

A Phase 1, Two-Way Crossover Study to Assess the Pharmacokinetics and Safety of a Single Dose of AG-221 in Healthy Male Subjects When Administered Under Fed and Fasted Conditions

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US Clinical Trial NCT01839019 – NIH – Apr 17, 2013

Safety, Tolerability and Pharmacokinetics of Single Escalating Doses of ODM-102: A Randomised, Double-blind, Placebo-controlled, Single Centre Study in Healthy Males

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US Clinical Trial NCT01575093 – NIH – Mar 11, 2012

The preparation regimen used for the PillCam® Colon 2 procedure consists of several colon cleansing materials. Different combinations of the above regimen were tested and evaluated for safety by monitoring of adverse events in multiple clinical stu...
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US Clinical Trial NCT01758432 – NIH – Dec 18, 2012

A Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445 After Dosing to Steady State With One of Four Direct/Indirect fXa Inhibitors in Healthy Volunteers

A randomized, double-blind, vehicle-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenously administered PRT064445 after dosing to steady state with one of four direct/indirect fXa inhibitors in h...
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US Clinical Trial NCT03375138 – NIH – Dec 13, 2017

A Randomized, Open-label, Parallel-group, Single-dose, Biocomparability Study of the Pharmacokinetics of Belatacept Drug Products Using Active Pharmaceutical Ingredient Manufactured by Process E PPQ Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Participants

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US Clinical Trial NCT03386279 – NIH – Dec 21, 2017

A Phase 1, Randomized, Placebo-and Positive-controlled Crossover Study To Determine The Effect Of Single-dose Pf-04965842 On Qtc Interval In Healthy Volunteers

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US Clinical Trial NCT01394224 – NIH – Jul 12, 2011

A Single Site, Open-label, Randomized, Single-dose, Two-way Cross-over Study in Healthy Japanese Subjects to Evaluate the Bioequivalence, Safety & Tolerability of Levetiracetam Administered as an Oral Tablet or Intravenous Infusion

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US Clinical Trial NCT01262794 – NIH – Dec 16, 2010

A Phase 1, Randomized, Double-blind, Placebo Controlled, Single-center, Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of CDP6038 Administered Subcutaneously to Healthy Japanese Males

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US Clinical Trial NCT02334449 – NIH – Nov 14, 2014

A First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study, to Assess the Safety, Tolerability and Pharmacokinetics of LML134 in Healthy Volunteers

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US Clinical Trial NCT01526083 – NIH – Jan 31, 2012

Single-center, Open-label, Randomized 2-way Crossover Study of the Effect of Lacosamide 200 mg Twice Daily on the Single-dose Pharmacokinetics and Pharmacodynamics of Warfarin (25 mg) in Healthy Male Volunteers

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US Clinical Trial NCT01359605 – NIH – May 19, 2011

An Open-Label, Single-Dose, Study to Assess the Metabolism and Elimination of Varespladib After Oral Administration of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects

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US Clinical Trial NCT01080417 – NIH – Mar 2, 2010

Open Label Balanced Randomized Two-treatment Two-period Two-sequence Single Dose Two-way Crossover Oral Bioequivalence Study of Mycophenolate Mofetil Capsules 250 mg in Normal Healthy Adult Human Subjects Under Fed Conditions

72 + 12 (stand-by) normal healthy adult subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at l...
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US Clinical Trial NCT01080482 – NIH – Mar 2, 2010

A Randomized, Single Dose, Open Label, Bioequivalence Study of Tacrolimus Capsules 5 mg in Normal Healthy Male Subjects Under Fasting Condition

Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least...
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US Clinical Trial NCT01080560 – NIH – Mar 2, 2010

A Randomized Single Dose Open Label Bioequivalence Study of Cyclosporine Capsules USP (Modified)100mg in Normal Healthy Male Subjects Under Fasting Condition

Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least...
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US Clinical Trial NCT01798628 – NIH – Oct 22, 2012

A Phase 1, Single Dose, Open-Label, Three-Period, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Subjects

This is an open-label (identity of assigned study drug will be known), randomized (treatment sequences will be assigned by chance) study of a single dose of abiraterone acetate 1000 mg administered orally (by mouth) in approximately 36 healthy male...
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US Clinical Trial NCT02001584 – NIH – Nov 15, 2013

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US Clinical Trial NCT02962739 – NIH – Nov 8, 2016

The Cellular Pharmacology of F-TAF in Dried Blood Spots

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US Clinical Trial NCT01080456 – NIH – Mar 2, 2010

A Randomized, Single Dose, Open Label, Bioequivalence Study of Tacrolimus Capsules 1 mg in Normal Healthy Male Subjects Under Fasting Condition

Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least...
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US Clinical Trial NCT01080586 – NIH – Mar 2, 2010

A Randomized Single Dose Open Label Bioequivalence Study of Cyclosporine Capsules USP (Modified)100mg in Normal Healthy Male Subjects Under Fed Condition

Total 78 normal healthy adult male subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least...
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US Clinical Trial NCT01725009 – NIH – Nov 7, 2012

A Single-center, Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Levetiracetam Administered as Intravenous Infusion in Japanese and Caucasian Healthy Male Subjects

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US Clinical Trial NCT01885624 – NIH – Jun 19, 2013

Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers

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US Clinical Trial NCT02265783 – NIH – Oct 3, 2014

Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable

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US Clinical Trial NCT02178059 – NIH – Jun 27, 2014

An Open-label, Single-dose, 2-period Cross Over Study in Healthy Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg After Inhalation Via the M3 Turbuhaler Compared With the M2 Turbuhaler

An Open-label, Single-dose, 2-period Cross over Study in Healthy Male and Female Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg after Inhalation via the M3 Turbuhaler (New Version) Compared with the M2 Turbuhaler (Curre...
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US Clinical Trial NCT01079689 – NIH – Mar 2, 2010

Brain Activity Changes Measured by EEG and fMRI on Healthy Volunteers After Complex Somatosensory Stimulation With Acupuncture Needles

The aim of the study is to evaluate whether the point locations chosen for a complex somatosensory stimulation with acupuncture needles have an essential impact on the change of brain activity in healthy volunteers. For this, the investigators compa...
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US Clinical Trial NCT01080469 – NIH – Mar 2, 2010

A Randomized, Single Dose, Open Label, Bioequivalence Study of Tacrolimus Capsules 1 mg in Normal Healthy Male Subjects Under Fed Condition

Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least...
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US Clinical Trial NCT01080534 – NIH – Mar 2, 2010

A Randomized, Single Dose, Open Label, Bioequivalence Study of Tacrolimus Capsules 5 mg in Normal Healthy Male Subjects Under Fed Condition

Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at least...
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US Clinical Trial NCT01055691 – NIH – Jan 25, 2010

A Two Part, Open Label, Randomized, Phase I Bioequivalence Study Comparing the Fixed Dose Combination Dapagliflozin/Metformin IR Tablet (2.5 mg/850 mg or 5 mg/1000 mg) vs. the Free Combination of Dapagliflozin and Metformin IR Tablets, in Healthy Volunteers, in the Fed State

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US Clinical Trial NCT01247103 – NIH – Nov 16, 2010

A Phase 1, Single-centre Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Dose, Parallel-group Study to Determine the Safety, Tolerability, and Pharmacokinetics of AZD4316 in Healthy Volunteers

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US Clinical Trial NCT02014272 – NIH – Dec 12, 2013

An Open Label, Single Dose, 2-Way Cross-Over Randomized Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 (Contains 150 Mg Rifampicin And 75 Mg Isoniazid Per Tablet) To An Equivalent Dose Of Single Drug Reference Preparations Of Rifampicin And Isoniazid Following Oral Administration In Healthy Adults Under Fasting Conditions

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US Clinical Trial NCT00856258 – NIH – Mar 3, 2009

A Phase 1, Double Blind (Sponsor Open), Randomized, Placebo Controlled, Parallel Group, Oral Multiple Dose Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF 03882845 In Healthy Volunteers

The study was terminated on June 19, 2009. Decision to terminate was based on Cohort 1 related safety concerns. An alternative clinical design was envisaged to better assess the benefit to risk.
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US Clinical Trial NCT01080443 – NIH – Mar 2, 2010

Open Label Balanced Randomized Two-treatment Two-period Two-sequence Single Dose Two-way Crossover Oral Bioequivalence Study of Mycophenolate Mofetil Capsules 250 mg in Normal Healthy Adult Human Subjects Under Fasting Conditions

48 +8 (stand-by) normal healthy adult subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 240 mL of water in each period as per the randomization schedule. Subjects will fast for at lea...
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US Clinical Trial NCT03101878 – NIH – Mar 6, 2017

A Blinded, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 757456 Administered Subcutaneously to Healthy Volunteers

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US Clinical Trial NCT02140281 – NIH – May 14, 2014

A Phase 1, Single-center, Randomized, 2-Way Cross-over, Open-label Study to Evaluate the Effect of Oral Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Cefadroxil in Healthy Volunteers

A Phase 1, Single-center, Randomized, 2-Way Cross-over, Open-label Study to Evaluate the Effect of Oral Repeated Doses of AZD1722 on the Pharmacokinetics of Oral Cefadroxil in Healthy Volunteers
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US Clinical Trial NCT02213315 – NIH – Aug 7, 2014

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Pharmacokinetics, Immunogenicity, and Safety of Mavrilimumab in Healthy Japanese Subjects

This is a Phase 1, randomized, double-blind, placebo-controlled, parallel group, single-dose study to evaluate the PK, immunogenicity, and safety of mavrilimumab at doses of 100 and 150 mg in healthy adult Japanese subjects. The study will be conduc...
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US Clinical Trial NCT03077282 – NIH – Feb 16, 2017

Quality Control and Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer

Sample size Group 1 (100mg/meal) = 6 female, 6 male Group 2 (200mg/meal) = 6 female, 6 male Volunteers will be divided into 2 groups. One will take Prasaprohyai 95% ethanolic extract capsules at a dose of 100 mg three times a day before meals and t...
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US Clinical Trial NCT02873767 – NIH – Aug 16, 2016

A Subject-Blind, Investigator-Blind, Randomized, Placebo-Controlled, First-In-Human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of UCB4019 in Healthy Subjects

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US Clinical Trial NCT00285506 – NIH – Jan 31, 2006

The Effect of Low-Osmolar and Iso-Osmolar Contrast Media on Erythrocytes in Healthy Volunteers.

The influence of several radiological contrast media on erythrocyte morphology and function has been investigated in the past (1). However, published data is sparse and does not include the assessment of iso-osmolar agents as compared to low-osmolar...
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US Clinical Trial NCT00296127 – NIH – Feb 22, 2006

A Relative Bioavailability Study Of Celecoxib Administered As Capsule Contents Sprinkled On Applesauce In Healthy Adult Volunteers

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US Clinical Trial NCT00301639 – NIH – Mar 10, 2006

A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults

OROS-MPH's pharmacokinetic profile uses an increasing delivery of MPH over the day (ascending pharmacokinetic curve). It was designed to replace IR-MPH TID treatment. Another new long-acting formulation is Metadate CD. Metadate CD consists of capsul...
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US Clinical Trial NCT00350155 – NIH – Jul 5, 2006

A 16-Day, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Trial Comparing Lumiracoxib 100mg o.d. With Naproxen 500 mg b.i.d. Plus Omeprazole 20mg o.d. and Placebo in Healthy Volunteers to Investigate on the Safety and Tolerability of Lumiracoxib in the Small Bowel.

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US Clinical Trial NCT00918164 – NIH – May 5, 2009

A Randomized, Open-Label, Single Dose, Crossover Study To Evaluate The Relative Bioavailability Of PF-04457845 Tablet To Solution Formulation And To Assess Food Effect In Healthy Subjects

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US Clinical Trial NCT00797342 – NIH – Nov 19, 2008

A Phase 1, Randomized, Double Blind (Sponsor Open), Placebo Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effect of PF-04629991 in Healthy Volunteers

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US Clinical Trial NCT00900913 – NIH – Oct 21, 2008

Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral

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US Clinical Trial NCT01012700 – NIH – Nov 11, 2009

A Randomized, Placebo-controlled, Phase I Study to Evaluate the Safety and Immunogenicity of Poly ICLC (Hiltonol) in Healthy Volunteers

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US Clinical Trial NCT00988403 – NIH – Sep 22, 2009

Investigation of Dietary Absorptive Capacity of Fructans in Healthy Subjects - A Randomized, Double-Blind Dose Response Study

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US Clinical Trial NCT00991016 – NIH – Oct 5, 2009

A Phase 1 Randomized, Double Blind (3rd Party Open), Placebo Controlled Combined Single And Multiple Dose Safety, Tolerability And Pharmacokinetics Study Of Orally Administered PF-04805712 In Healthy Volunteers

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US Clinical Trial NCT01056575 – NIH – Jan 25, 2010

An Open Label Balanced Study in Healthy Subjects to Evaluate the Potential for Cytochrome P 450 3A4 Induction by Oral OC000459 Using Oral Midazolam as a Probe

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