Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers
NCT03662620 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2024-11-12
Summary
This is a phase 1, randomized, open label, single-dose, replicate crossover clinical trial to compare the safety and pharmacokinetics of YH22162 in healthy male volunteers.
Hypothesis: Study drug and comparator drug are showing equal pharmacokinetics.
Conditions
Interventions
- DRUG
-
Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
White colored oval three-layer tablet
- DRUG
-
Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
White and pink colored oval two-layer tablet
Sponsors & Collaborators
-
Yuhan Corporation
lead INDUSTRY
Principal Investigators
-
Mingul Kim, MD · Chonbuk National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-10-05
- Primary Completion
- 2018-12-08
- Completion
- 2018-12-22
Countries
- South Korea
More Related Trials
-
A Bioequivalence Study Between Telmione 80 mg and Micardis 80 mg in Healthy Adult Volunteers
NCT05223101 ·Status: UNKNOWN ·Phase: PHASE1
-
Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone
NCT01806363 ·Status: COMPLETED ·Phase: PHASE1
-
Compare the Pharmacokinetics of TAH(80/10/12.5) Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers
NCT03032315 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension
NCT06282549 ·Status: ACTIVE_NOT_RECRUITING
-
CKD-828 (80/5mg) Pharmacokinetic Study
NCT02250833 ·Status: COMPLETED ·Phase: PHASE1
-
CKD-828 (40/5mg) Pharmacokinetic Study
NCT01340131 ·Status: COMPLETED ·Phase: PHASE1
-
Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)
NCT02152969 ·Status: COMPLETED ·Phase: PHASE1
-
S-amlodipine+Chlorthalidone vs S-amlodipine+Telmisartan in Hypertension
NCT03226340 ·Status: UNKNOWN ·Phase: PHASE4
-
CKD-828(80/2.5mg) Pharmacokinetic Study_2nd
NCT01352689 ·Status: COMPLETED ·Phase: PHASE1
-
A Bioequivalence Study Between Telmione Plus 80/12.5mg and Micardis Plus 80/12.5 mg in Healthy Adult Volunteers
NCT05040880 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of Telmisartan Alone and in Combination With Amlodipine in Healthy Volunteers
NCT02259816 ·Status: COMPLETED ·Phase: PHASE1
-
CKD-828(80/2.5mg) Pharmacokinetic Study
NCT01246193 ·Status: COMPLETED ·Phase: PHASE1
-
CKD-828 (80/5mg) Pharmacokinetic Study
NCT02358824 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of TAH Combination in Comparison With Telmisartan/Amlodipine Combination for Essential Hypertension Patients
NCT02738632 ·Status: COMPLETED ·Phase: PHASE3
-
Relative Bioavailability of Telmisartan/Amlodipine Fixed-dose Combination Compared to Its Mono-components in Healthy Male Volunteers
NCT02259803 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of UI15AML055MT and Amosartan® Tablet 5/50 mg After a Single Oral Administration in Healthy Male Volunteers
NCT02166398 ·Status: COMPLETED ·Phase: PHASE1
-
CKD-828 Primary Hypertension Trial(Dose-selection)
NCT01128322 ·Status: COMPLETED ·Phase: PHASE2
-
CKD-828 Drug Interaction Study (S-amlodipine)
NCT01356043 ·Status: COMPLETED ·Phase: PHASE1
-
Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine
NCT01911780 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015 and Co-administration of BR1015-1 and BR1015-2 in Healthy Volunteers Fed Conditions
NCT06744062 ·Status: COMPLETED ·Phase: PHASE1
-
Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
NCT03629067 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of CKD-828 to Stage 2 Hypertension
NCT01634295 ·Status: COMPLETED ·Phase: PHASE3
-
Relative Bioavailability of Telmisartan and HCTZ in Two Experimental Formulations Compared to the Standard Formulation Telmisartan and HCTZ in Healthy Female and Male Subjects
NCT02262572 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan/5 mg Amlodipine and 80 mg Telmisartan/5 mg Amlodipine in Healthy Male Volunteers
NCT02194309 ·Status: COMPLETED ·Phase: PHASE1
-
CKD-828 Telmisartan Non-Responder Trial
NCT01426100 ·Status: COMPLETED ·Phase: PHASE3