NCT02801526CompletedPhase 1
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 (A)
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 32
- Primary Endpoint
- AUCt
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Candesartan and Amlodipine
Experimental
Candesartan 16mg and Amlodipine 5mg, PO, 1days or 22days
Intervention: Candesartan 16mg and Amlodipine 5mg (Drug)
CKD-330
Experimental
CKD-330 16/5mg - A, PO, 1days or 22days
Intervention: CKD-330 16/5mg - A (Drug)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- AUCinf(0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr)
- tmax(0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr)
- t1/2β(0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr)
- CL/F(0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr)
Investigators
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