Bioequivalence Study (Candesartan 16 mg and Amlodipine 10 mg)

HanAll Biopharma

Status and phase

Completed

Phase 1

Conditions

Hypertension

Treatments

Drug: HL068 16/10mg

Drug: Candesartan 16mg and Amlodipine 10mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02988362

HL068

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

Male

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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