A Randomized, Open-label, Single Dose, Replicate Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Cmax of Telmisartan/amlodipine/chlorthalidone
Study Overview
Brief 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.
Detailed Description
In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.
In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
- •Who has not suffered from clinically significant disease
- •Provision of signed written informed consent
Exclusion Criteria
- •History of and clinically significant disease
- •Administration of other investigational products within 3 months prior to the first dosing
- •Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
Arms & Interventions
ARM1
In ARM1, 32 subjects will be assigned and the subjects will be administered "comparator drug" at Day1/Day43 and "study drug" at Day22/64.
Intervention: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg (Drug)
ARM2
In ARM2, 32 subjects will be assigned and the subjects will be administered "study drug" at Day1/Day43 and "comparator drug" at Day22/64.
Intervention: Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg (Drug)
Outcomes
Primary Outcomes
Cmax of Telmisartan/amlodipine/chlorthalidone
Time Frame: 0-168 hrs
Cmax
AUClast of Telmisartan/amlodipine/chlorthalidone
Time Frame: 0-168 hrs
AUClast
Secondary Outcomes
- t1/2 of Telmisartan/amlodipine/chlorthalidone(0-168 hrs)
- AUCinf of Telmisartan/amlodipine/chlorthalidone(0-168 hrs)
- Tmax of Telmisartan/amlodipine/chlorthalidone(0-168 hrs)