Clinical trials: Healthy Adult Male
Healthy Volunteers
A Safety, Tolerability and Pharmacokinetics Study of TransCon Treprostinil in Healthy Adult Male Volunteers
To determine the maximum tolerated dose (MTD) and assess safety and tolerability of escalating single doses of TransCon PEG treprostinil administered as a subcutaneous injection to healthy male volunteers.
- Trial name
- NCT03803163
- Testing
- TransCon Treprostinil
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Ascendis Pharma A/S
Drug Interaction Potentiation
A Drug-Drug Interaction Study of Digoxin and PA21
The purpose of this study is to determine if Digoxin is affected by PA21.
- Trial name
- NCT01477411
- Testing
- PA21, Digoxin
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Vifor Pharma
Healthy Subjects
An Open-label Trial to Evaluate Mass Balance of Tavapadon at Steady State in Healthy Subjects
The purpose of this trial is to determine the absorption, metabolism, and excretion (AME) of [14C] tavapadon.
- Trial name
- NCT04241393
- Testing
- Tavapadon tablet, Tavapadon [14C] suspension
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cerevel Therapeutics, LLC
Pharmacokinetics
Fasted Bioequivalence Study of 2 Olanzapine Film-coated Tablets, 5 mg, in Healthy, Adult Male and Female Subjects.
This study was designed to assess the bioequivalence of Olanzapine tablets of two different manufacturers and to investigate the safety and tolerability of Olanzapine tablets of two different manufacturers.
- Trial name
- NCT05123976
- Testing
- Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine), Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)
- Where
- Czechia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
Healthy
Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions
The objective of this study was to evaluate the relative bioavailability of the test formulation of finasteride 5 mg tablets (Dr.
- Trial name
- NCT01264289
- Testing
- Finasteride
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Gout
Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence.
To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fasted state based on the pharmacokinetic (PK) evaluation of lesinurad and allopurinol in…
- Trial name
- NCT03272425
- Testing
- lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg, allopurinol 300 mg
- Where
- Brazil
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ardea Biosciences, Inc.
Focal Onset Seizure
A Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered Cannabidiol Capsules (AVAT-121) and Epidyolex® in Healthy Adults
This Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of AVAT-121 in healthy adults. The study includes three parts: Part A: single ascending dose.
- Trial name
- NCT07918469
- Testing
- AVAT-121, AVAT-121 and Epidyolex®
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Avata Biosciences Holdings Ltd
Renal Impairment, Healthy Volunteers
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to Adult Participants With Severe Renal Impairment Compared to Matched Participants With Normal Renal Function
The purpose of this Phase 1, open-label, 2-arm study is to assess the effect of severe RI on PK, safety, and tolerability of rilzabrutinib compared with normal renal function, in male and female participants aged from 18 to 75…
- Trial name
- NCT07853131
- Testing
- rilzabrutinib
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sanofi
Renal Impairment, Healthy
Study of ALXN2050 in Participants With Renal Impairment
This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with impaired renal function.
- Trial name
- NCT04623710
- Testing
- ALXN2050
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Depression
To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fasting Conditions
To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions.
- Trial name
- NCT00913718
- Testing
- Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.), Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Sandoz
Healthy Volunteers, Healthy
A Study to Investigate the Absorption, Metabolism, Excretion, and Mass Balance of GC4419 in Healthy Adult Subjects
GC4419 is being studied to treat and prevent oral mucositis (painful inflammation) in cancer patients who receive radiation and chemotherapy.
- Trial name
- NCT03163173
- Testing
- GC4419
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Galera Therapeutics, Inc.
Healthy
A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fed Condition
The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Valacyclovir hydrochloride tablets 1 gram manufactured by OHM…
- Trial name
- NCT01222897
- Testing
- Valacyclovir hydrochloride
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
A Multiple Dose Study To Determine Safety, Tolerability, and Pharmacokinetics Of PF-04634817 In Healthy Adult Subjects
The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects.
- Trial name
- NCT01140672
- Testing
- PF-04634817
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Pfizer
ADME, Healthy
A Study to Evaluate the Mass Balance of 14C-Napabucasin in Healthy Adult Male Subjects
This is a Phase I, single-center, open-label, single-sequence, study evaluating the absorption, metabolism, and excretion of napabucasin in healthy adult male volunteers using a mixture 14C-radiolabeled and unlabeled material.
- Trial name
- NCT03525405
- Testing
- napabucasin
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Sumitomo Pharma America, Inc.
Healthy
Bioequivalence Study of Ramipril 10 mg Capsules Under Fed Conditions
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing ramipril 10 mg capsules of Ohm Laboratories Inc., with Altace®…
- Trial name
- NCT00879788
- Testing
- Ramipril 10mg capsules
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Renal Impairment
A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function
The purpose of this study is to understand how the loss of kidney function affects study medicine (PF-07923568) in the body. People with some level of loss of kidney function may process PF-07923568 differently from healthy…
- Trial name
- NCT06037031
- Testing
- Drug: PF-07923568
- Where
- 6 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study of JNJ-61393215 in Healthy Japanese Male Participants
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) after single dose administrations of JNJ-61393215 in Japanese healthy adult male participants.
- Trial name
- NCT04713930
- Testing
- JNJ-61393215
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
Healthy Male
Study of Aldafermin (NGM282) in Healthy Adult Male Japanese and Non-Japanese Subjects
This is an open-label study to assess safety, tolerability, and pharmacokinetics of Aldafermin (NGM282) in healthy adult male Japanese and non-Japanese subjects
- Trial name
- NCT04828265
- Testing
- Aldafermin
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- NGM Biopharmaceuticals, Inc
To Determine Bioequivalence Under Fed Conditions
The Study Intends to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Evaluated.
To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 1000/50 mg manufactured by Oman Pharmaceuticals Products Co.
- Trial name
- NCT05329857
- Testing
- Metformin and Vildagliptin 1000/50 mg
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AET Laboratories Private Limited
Rheumatoid Arthritis
Safety,PK/PD, Food Effect Study of Orally Administered HM71224 in Healthy Adult Male Volunteers
HM71224 is a potent small molecule inhibitor of Bruton's tyrosine kinase (BTK). BTK is a member of the Tec family of non-receptor protein tyrosine kinases.
- Trial name
- NCT01765478
- Testing
- HM71224 single ascending dose, HM71224 food effect, HM71224 Multiple ascending dose
- Where
- Netherlands
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited