Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)
NCT02988362 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2025-04-04
Summary
The purpose of this study is to compare the safety and pharmacokinetics of HL068 (Candesartan 16 mg and Amlodipine 10mg) with coadministration of the two separate drugs in healthy male volunteers.
Conditions
Interventions
- DRUG
-
HL068 16/10mg
Candesartan 16mg and Amlodipine 10mg
- DRUG
-
Candesartan 16mg and Amlodipine 10mg
Sponsors & Collaborators
-
HanAll BioPharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Young-Ran Yoon, M.D, Ph.D · KYUNGPOOK NATIONAL UNIVERSITY HOSPITAL CLINICAL TRIAL CENTER
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
- 2016-12-14
- Primary Completion
- 2017-02-04
- Completion
- 2017-02-04
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