Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - A

Chong Kun Dang

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Candesartan 16mg and Amlodipine 5mg; Drug: CKD-330 16/5mg - A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02801526

144BE15005

Details and patient eligibility

About

The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.

Enrollment: 32 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male volunteer in the age between 19 and 45 years old.
2. Body weight ≥ 55 kg and Body weight in the range of calculated IBW ±20%.
3. Subjects without a hereditary problems and chronic disease.
4. Subjects whose clinical laboratory test values are inside the accepted normal range.
5. Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion criteria

1. Previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system.
2. History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
3. History of clinically significant allergies of amlodipine or candesartan or CCB or ARB or aspirin or antibiotic.
4. Subjects with galactose intolerance.
5. SBP ≥ 140 mmHg or< 90 mmHg, DBP ≥ 95 mmHg or < 60 mmHg, pulse ≥ 100 BPM.
6. AST or ALT > 2*ULN, total bilirubin > 2*ULN
7. Serum Creatinine > ULN
8. Previous history or present of drug abuse.
9. Subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing.
10. Subjects treated ethical drug or herbal medicine within 2 weeks, OTC or vitamin within 1 week prior to the first dosing.
11. Subjects treated IP within 2 months prior to the first dosing.
12. Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.
13. Alcohol > 21 units/week or cannot stop drinking.
14. Cigarette > 10 cigarettes/day.
15. Subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - LASIK, LASEK).
16. Not eligible to participate for the study at the discretion of investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Candesartan and Amlodipine

Experimental group

Description:

Candesartan 16mg and Amlodipine 5mg, PO, 1days or 22days

Treatment:

Drug: Candesartan 16mg and Amlodipine 5mg

CKD-330

Experimental group

Description:

CKD-330 16/5mg - A, PO, 1days or 22days

Treatment:

Drug: CKD-330 16/5mg - A