Healthy Male Volunteers Clinical Trial
Official title:
A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between LGEV1801 and LGEV1802 in Healthy Korean Male Volunteers
| Verified date | February 2019 |
| Source | LG Chem |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and LGEV1802 in healthy male volunteers.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | January 30, 2019 |
| Est. primary completion date | August 25, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 19 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - Healthy male - Age between 19 and 50 - Subjects with BMI of 18~27 kg/m2 with a weight of 55kg or more - Subjects with SBP of 90~150 mmHg and DBP of 60~150 mmHg - Signed informed consent Exclusion Criteria: - Presence of medical history or a concurrent disease - Has a history of hypersensitivity to IP ingredients |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | LG chem | Seoul | Gangseo-Gu |
| Lead Sponsor | Collaborator |
|---|---|
| LG Chem |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | AUCT,ss | Day 1~Day 8 | ||
| Primary | Cmax,ss | Day 1~ Day 8 |
| 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 | |
| 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 |
NCT01382017 -
Effects of Lacosamide on Human Motor Cortex Excitability: a Transcranial Magnetic Stimulation Study
|
N/A | |
| Completed |
NCT01606462 -
Oxytocin and Social Cognition
|
Phase 1 | |
| Completed |
NCT01356017 -
CKD-828 Drug Interaction Study (Telmisartan)
|
Phase 1 |