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Study to Compare the Safety and Pharmacokinetics of CKD-330 8/5mg With Coadministration of the Two Separate Drugs

NCT ID: NCT02548286

Last Updated: 2015-12-07

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

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2015-09-30

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 Cilexetil 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, 1day or 22day

Group Type ACTIVE_COMPARATOR

Candesartan 8mg

Intervention Type DRUG

PO, 1day or 22day

Amlodipine 5mg

Intervention Type DRUG

PO, 1day or 22day

CKD-330

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

Group Type EXPERIMENTAL

CKD-330 8/5mg

Intervention Type DRUG

PO, 1day or 22day

Interventions

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Candesartan 8mg

PO, 1day or 22day

Intervention Type DRUG

Amlodipine 5mg

PO, 1day or 22day

Intervention Type DRUG

CKD-330 8/5mg

PO, 1day or 22day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male volunteer in the age of 19-45
2. Body weight ≥ 55 kg and in the range of calculated IBW ±20%
3. Subject without a hereditary problems, chronic disease and morbid symptom
4. Suitable clinical laboratory test values
5. Subject who sign on an informed consent form willingly

Exclusion Criteria

1. Clinically significant disease with hepatobiliary, nephrological, neurologic, respiratory, haemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
2. Gastrointestinal disease or gastrointestinal surgery
3. History of significant hypersensitivity reaction of amlodipine, candesartan, calcium channel blocker, angiotensin II receptor blocker or other drugs
4. Galactose intolerance
5. Sitting systolic blood pressure ≥ 140 mmHg or\< 90 mmHg, sitting diastolic blood pressure ≥ 95 mmHg or \< 60 mmHg, pulse ≥ 100 beats per minute
6. Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin \> 2 x upper limit of normal range
7. Serum Creatinine \> upper limit of normal range
8. Drug abuse
9. Subject treated metabolizing enzyme inducers or inhibitors within 1 month
10. Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week
11. Subject treated Investigational product(include Bioequivalence test) within 3 months
12. Whole blood donation within 2 months, component blood donation or blood transfusion within 1 month
13. Continuously taking Alcohol \> 21 units/week
14. Cigarette \> 10 cigarettes/day
15. Subjects with planning of dental treatment or any surgery
16. Another clinical condition in judgement of investigator
Minimum Eligible Age

19 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, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Locations

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Chungnam National University Hospital

Daejeon, Jung-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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144BE15015

Identifier Type: -

Identifier Source: org_study_id