Clinical trials: Healthy Male Subjects
Healthy Male Subjects
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male…
- Trial name
- NCT05245669
- Testing
- ENZ215, EU Sourced Prolia, US Sourced Prolia
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Enzene Biosciences Ltd.
Healthy
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed…
- Trial name
- NCT03247673
- Testing
- CT-P16, EU-approved Avastin, US-licensed Avastin
- Where
- 3 sites in South Korea
- Volunteers
- 141 people, healthy volunteers welcome
- Sponsor
- Celltrion
Parkinson's Disease (PD)
An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites
The purpose of this study is to determine the rate and routes of excretion of OPC and the mass balance in urine, faeces and expired air.
- Trial name
- NCT02169427
- Testing
- OPC
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy
Drug-drug Interaction Trial Between Rifampicin and BI 409306 in Healthy Volunteers
The primary objective of this trial is to investigate the relative bioavailability of BI 409306 tablets with prior 7-day intake of rifampicin tablets (Test, T) compared to BI 409306 tablets without prior administration of…
- Trial name
- NCT03151499
- Testing
- BI 409306, Rifampicin
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test Whether Food Affects the Amount of BI 894416 in the Blood
Investigate the relative bioavailability of BI 894416 as tablet formulation following a high-fat, high calorie breakfast (Test, T) compared with administration in the fasting state (Reference, R)
- Trial name
- NCT03871595
- Testing
- BI 894416
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus, Type 2
A Single-dose Phase 1 Study of DBPR108 in Healthy Male Subjects
The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties of single oral doses of DBPR108 in healthy male subjects.
- Trial name
- NCT01650324
- Testing
- DBPR108
- Where
- Taiwan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Health Research Institutes, Taiwan
Erectile Dysfunction
Pharmacokinetics Of Sildenafil Orally Disintegrating Tablet Formulation Given With Or Without Food.
This study will evaluate if an orally disintegrating tablet of sildenafil will have similar pharmacokinetic properties when given with food and without food.
- Trial name
- NCT01254396
- Testing
- Sildenafil
- Where
- Singapore
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Clinical Pharmacology
TAK-114 Single- and Multiple-Dose Phase 1 Study
The purpose of this study is to evaluate the safety and tolerability of TAK-114 following single and multiple ascending oral doses in healthy Japanese male participants.
- Trial name
- NCT02286518
- Testing
- TAK-114 10 mg capsule
- Where
- Japan
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Takeda
Filariasis
Relative Bioavailability Study of Emodepside IR-tablets and Solution
This study evaluates 2 new immediate release (IR)-tablet formulations of emodepside and they will be compared to the oral liquid service formulation (LSF) used in the FIH Single Ascending Dose study (DNDi-EMO-001 study) (CT.gov…
- Trial name
- NCT03383523
- Testing
- Emodepside (BAY 44-4400)
- Where
- United Kingdom
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Healthy
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants
The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clearance in healthy participants…
- Trial name
- NCT03261401
- Testing
- M5717
- Where
- Australia
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Safety, Tolerability
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 After Single Ascending Doses to Healthy Males
This study will be a randomized, single-blind, placebo-controlled first-in-human study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of single ascending doses of AZD9977.
- Conditions
- Safety, Tolerability, Pharmacokinetics, Healthy Subjects
- Trial name
- NCT02484729
- Testing
- AZD9977, oral suspension, AZD9977, oral solution
- Where
- United Kingdom
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Post-operative Nausea and Vomiting
Mass-balance Study of [14C]-APD421 in Healthy Volunteers
Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass balance recovery, metabolite profile, metabolite identification and pharmacokinetics of 14C-labelled APD421
- Trial name
- NCT02881840
- Testing
- 14C-APD421
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Acacia Pharma Ltd
Healthy
Single Rising Dose Trial of BI 425809 for Healthy Japanese and Chinese Male Subjects
To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy Chinese and Japanese male subjects following the administration of single rising oral doses and further to explore the pharmacokinetics…
- Trial name
- NCT02383888
- Testing
- BI 425809
- Where
- South Korea
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809
To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate…
- Trial name
- NCT02068690
- Testing
- BI 425809 PfOS, BI 425809 tablet
- Where
- Germany
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood
To establish the bioequivalence of one fixed dose combination (FDC) tablet of empagliflozin/linagliptin/metformin extended release (XR) versus the free combination of empagliflozin tablet, linagliptin tablet, and metformin XR…
- Trial name
- NCT03259490
- Testing
- Empagliflozin/linagliptin/metformin HCl, Empagliflozin, Linagliptin
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1467335 Following Multiple Dose Administration Over 28 Days
The primary objective of this trial is to investigate the safety and tolerability of BI 1467335 in healthy male and female subjects following oral administration of multiple rising doses over 28 days.
- Trial name
- NCT02733627
- Testing
- BI 1467335
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 706321 in the Blood
To investigate the pharmacokinetics of a single oral dose of BI 706321 when given alone or in combination with itraconazole.
- Trial name
- NCT04714073
- Testing
- BI 706321, Itraconazole
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects
This single-center, open-label, non randomized Phase I study is being conducted to investigate the pharmacokinetics, mass balance and metabolite profiling and identification after a single oral dose of 100mg of [14C]-MD1003 in 6…
- Trial name
- NCT04223232
- Testing
- [14C]-MD1003
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- MedDay Pharmaceuticals SA
Congestive Heart Failure
Phase I Study of OPC-61815
To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on QT/QTc interval in healthy male subjects
- Trial name
- NCT03510663
- Testing
- OPC-61815 16mg, OPC-61815 32mg, Moxifloxacin
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Healthy Volunteers
Study of Prasugrel in Korean Healthy Male Volunteers
The purpose of this study is to investigate how the body processes prasugrel and how prasugrel affects blood clotting in healthy Korean men. Three different dosing regimens of prasugrel will be given.
- Trial name
- NCT01591317
- Testing
- Prasugrel
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company