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Bioequivalence Study (Candesartan 8 mg and Amlodipine 5 mg)

NCT ID: NCT02186496

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-11-30

Brief Summary

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The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 8 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Candesartan and Amlodipine

Candesartan 8mg and Amlodipine 5mg, PO, 1days or 22days

Group Type EXPERIMENTAL

Candesartan 8mg and Amlodipine 5mg

Intervention Type DRUG

CKD-330

CKD-330 8/5mg, PO, 1days or 22days

Group Type EXPERIMENTAL

CKD-330 8/5mg

Intervention Type DRUG

Interventions

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CKD-330 8/5mg

Intervention Type DRUG

Candesartan 8mg and Amlodipine 5mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male volunteer in the age between 20 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

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jang Hee Hong

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Locations

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Chungnam National University Hospital

Daejeon, North Chungcheong, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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144BE14002

Identifier Type: -

Identifier Source: org_study_id