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

NCT ID: NCT02811731

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-08-31

Brief Summary

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Candesartan and Amlodipine

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

Group Type: EXPERIMENTAL

Candesartan 16mg and Amlodipine 5mg

Intervention Type: DRUG

CKD-330

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

Group Type: EXPERIMENTAL

CKD-330 16/5mg - B

Intervention Type: DRUG

Interventions

CKD-330 16/5mg - B

Intervention Type: DRUG

Candesartan 16mg and Amlodipine 5mg

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jang Hee Hong

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Other Identifiers

144BE15006

Identifier Type: -

Identifier Source: org_study_id