Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Candesartan 16mg and Amlodipine 10mg; Drug: HL068 16/10mg

• Registration Number: NCT02988362
• Lead Sponsor: HanAll BioPharma Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-09
• Study Start: 2016-12-14
• Primary Completion: 2017-02-04
• Study Completion: 2017-02-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

• Healthy male volunteer in the age between 19 and 55 years old.
• Body mass index (BMI) in the range of 18.5 to 27.0 kg/m2
• Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria

• Previous history or present of clinically significant digestive , cardiovascular, respiratory, psychiatric, endocrine, hepatobiliary, renal disease.
• History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
• Subjects with a hereditary problems, for example, galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• Subjects whose clinical laboratory test values are outside the accepted normal range. Especially, ASTor ALT >1.5 times of the Upper Normal Limit or total bilirubin > 1.5 times of the Upper Normal Limit
• Positive test results for Hepatitis B antibodies, Hepatitis C virus antibody, and Syphilis regain test
• Participation in any clinical investigation within 3 months prior to study drug administration
• Subjects with whole blood donation within 60 days or component blood donation within 30days or blood transfusion within 30days prior to the first dosing.
• SBP ≥ 140 mmHg or< 115 mmHg, DBP ≥ 90 mmHg or < 70 mmHg
• Caffeine > 400mg/day
• Alcohol > 30g/day
• Cigarette > 10 cigarettes/day.
• Subjects who are judged unsuitable by investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Candesartan 16mg and Amlodipine 10mg	Candesartan 16mg and Amlodipine 10mg	Candesartan 16mg and Amlodipine 10mg
HL068	HL068 16/10mg	HL068(combination of Candesartan 16 mg and Amlodipine 10 mg)

Primary Outcome Measures

Name	Time	Method
Cmax	up to 72 hours
AUCt	up to 72 hours

Secondary Outcome Measures

Name	Time	Method
Tmax	up to 72 hours
t 1/2β	up to 72 hours
AUCinf	up to 72 hours
CL/F	up to 72 hours