Healthy Male Volunteers Clinical Trial
Official title:
A Randomized, Open-label, Oral Single Dosing, Two-way Crossover Clinical Trial to Compare the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of the Fixed-dose Combinations of Gemigliptin/Metformin HCl Sustained Release 50/1000 mg (25/500 mg x 2 Tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 1000 mg (500mg x 2 Tablets) Under Fasting and Fed Conditions in Healthy Male Volunteers
This study is to compare the safety/tolerability and pharmacokinetics/pharmacodynamics of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg (25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl extended release 1000 mg (500mg x 2 tablets) under fasting and fed conditions in healthy male volunteers.
This study will be conducted in separtes 2 Parts.
Part I is designed to compare the safety/tolerability and pharmacokinetics/pharmacodynamics
of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg
(25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl
extended release 1000 mg (500mg x 2 tablets) under fasting condition.
Part II is designed to compare the safety/tolerability and pharmacokinetics/pharmacodynamics
of the fixed-dose combinations of gemigliptin/metformin HCl sustained release 50/1000 mg
(25/500 mg x 2 tablets) in comparison to each component gemigliptin 50 mg and metformin HCl
extended release 1000 mg (500mg x 2 tablets) under fed conditions.
In total, 70 subjects will be enrolled in this study;Part I: 40, Part II :30 subjects.
the study design and arms are the same in both parts.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05523687 -
AME Study of [14C]-PC14586 in Healthy Male Participants
|
Phase 1 | |
| Completed |
NCT02250976 -
The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca
|
Phase 1 | |
| Completed |
NCT01948011 -
Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules
|
Phase 1 | |
| Completed |
NCT04086719 -
An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.
|
Phase 1 | |
| Completed |
NCT03686501 -
D1 Receptor Occupancy (RO) Following a Single Dose of PF-06412562
|
Early Phase 1 | |
| Terminated |
NCT01965301 -
First-time-in-man, to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375
|
Phase 1 | |
| Completed |
NCT01005160 -
Drug Interaction Between CKD-501 and Metformin
|
Phase 1 | |
| Completed |
NCT04534582 -
Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects
|
Phase 1 | |
| Recruiting |
NCT06159101 -
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects
|
Phase 1 | |
| Completed |
NCT01549743 -
The Pharmacokinetic Interaction Between Celecoxib and Rebamipide
|
Phase 1 | |
| Completed |
NCT03532854 -
Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802
|
Phase 1 | |
| Recruiting |
NCT03530228 -
A Phase 1 Study of Tegoprazan on Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT01356043 -
CKD-828 Drug Interaction Study (S-amlodipine)
|
Phase 1 | |
| Completed |
NCT04810533 -
The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT03089112 -
Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501
|
Phase 1 | |
| Completed |
NCT01939639 -
The Influence of Oxytocin on the Processing of Social Contact
|
Phase 1 | |
| Completed |
NCT01342055 -
Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers
|
Phase 1 | |
| Terminated |
NCT03863587 -
Compare Pharmacokinetic, Safety, Tolerability and Immunogenicity of HLX12 and Ramucirumab in Healthy Male Adult Subjects
|
Phase 1 | |
| Completed |
NCT01356017 -
CKD-828 Drug Interaction Study (Telmisartan)
|
Phase 1 | |
| Completed |
NCT01382017 -
Effects of Lacosamide on Human Motor Cortex Excitability: a Transcranial Magnetic Stimulation Study
|
N/A |