Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: HanAll BioPharma Co., Ltd.
• Treatments: Amlodipine; Candesartan; Candesartan cilexetil

Criteria

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