- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02811731
Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - B
A Randomized, Open-label, Single-dosing, 2x2 Crossover Study 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 (B)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male volunteer in the age between 19 and 45 years old.
- Body weight ≥ 55 kg and Body weight in the range of calculated IBW ±20%.
- Subjects without a hereditary problems and chronic disease.
- Subjects whose clinical laboratory test values are inside the accepted normal range.
- Understand the requirements of the study and voluntarily consent to participate in the study.
Exclusion Criteria:
- Previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system.
- History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
- History of clinically significant allergies of amlodipine or candesartan or CCB or ARB or aspirin or antibiotic.
- Subjects with galactose intolerance.
- SBP ≥ 140 mmHg or< 90 mmHg, DBP ≥ 95 mmHg or < 60 mmHg, pulse ≥ 100 BPM.
- AST or ALT > 2*ULN, total bilirubin > 2*ULN
- Serum Creatinine > ULN
- Previous history or present of drug abuse.
- Subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing.
- Subjects treated ethical drug or herbal medicine within 2 weeks, OTC or vitamin within 1 week prior to the first dosing.
- Subjects treated IP within 2 months prior to the first dosing.
- 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.
- Alcohol > 21 units/week or cannot stop drinking.
- Cigarette > 10 cigarettes/day.
- Subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - LASIK, LASEK).
- Not eligible to participate for the study at the discretion of investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Candesartan and Amlodipine
Candesartan 16mg and Amlodipine 5mg, PO, 1days or 22days
|
|
Experimental: CKD-330
CKD-330 16/5mg - B, PO, 1days or 22days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCt
Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
|
A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
|
Cmax
Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
|
A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCinf
Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
|
A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
|
tmax
Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
|
A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
|
t1/2β
Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
|
A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
|
CL/F
Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
|
A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr |
0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jang Hee Hong, Chungnam National University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Candesartan
Other Study ID Numbers
- 144BE15006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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