NCT02548286CompletedPhase 1
A Randomized, Open-label, Single-dosing, Crossover Study 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(B)
Chong Kun Dang Pharmaceutical1 site in 1 country53 target enrollmentStarted: August 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- AUCt(Area Under the Plasma Concentration-time curve) of Candesartan
Study Overview
Brief Summary
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.
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 of 19-45
- •Body weight ≥ 55 kg and in the range of calculated IBW ±20%
- •Subject without a hereditary problems, chronic disease and morbid symptom
- •Suitable clinical laboratory test values
- •Subject who sign on an informed consent form willingly
Exclusion Criteria
- •Clinically significant disease with hepatobiliary, nephrological, neurologic, respiratory, haemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system
- •Gastrointestinal disease or gastrointestinal surgery
- •History of significant hypersensitivity reaction of amlodipine, candesartan, calcium channel blocker, angiotensin II receptor blocker or other drugs
- •Galactose intolerance
- •Sitting systolic blood pressure ≥ 140 mmHg or< 90 mmHg, sitting diastolic blood pressure ≥ 95 mmHg or < 60 mmHg, pulse ≥ 100 beats per minute
- •Aspartate aminotransferase, Alanine aminotransferase, Total bilirubin > 2 x upper limit of normal range
- •Serum Creatinine > upper limit of normal range
- •Subject treated metabolizing enzyme inducers or inhibitors within 1 month
- •Subject treated ethical the counter or herbal medicine within 2 weeks, over-the-counter or vitamin within 1 week
- •Subject treated Investigational product(include Bioequivalence test) within 3 months
- •Whole blood donation within 2 months, component blood donation or blood transfusion within 1 month
- •Continuously taking Alcohol > 21 units/week
- •Cigarette > 10 cigarettes/day
- •Subjects with planning of dental treatment or any surgery
- •Another clinical condition in judgement of investigator
Arms & Interventions
Candesartan and Amlodipine
Active Comparator
Candesartan 8mg and Amlodipine 5mg, PO, 1day or 22day
Intervention: Candesartan 8mg (Drug)
Candesartan and Amlodipine
Active Comparator
Candesartan 8mg and Amlodipine 5mg, PO, 1day or 22day
Intervention: Amlodipine 5mg (Drug)
CKD-330
Experimental
CKD-330 8/5mg, PO, 1day or 22day
Intervention: CKD-330 8/5mg (Drug)
Outcomes
Primary Outcomes
AUCt(Area Under the Plasma Concentration-time curve) of Candesartan
Time Frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
Cmax(Maximum Plasma Concentration) of Amlodipine
Time Frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
Cmax(Maximum Plasma Concentration) of Candesartan
Time Frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr
AUCt(Area Under the Plasma Concentration-time curve) of Amlodipine
Time Frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr
Secondary Outcomes
- CL/F(Clearance/Bioavailability) of Candesartan(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr)
- AUCinf(Area Under the Plasma Concentration-time curve from time t to infinity) of Amlodipine(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr)
- tmax(Time to reach the maximum concentration) of Amlodipine(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr)
- t1/2β(Time for C max to drop in half) of Candesartan(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr)
- t1/2β(Time for C max to drop in half) of Amlodipine(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr)
- AUCinf(Area Under the Plasma Concentration-time curve from time t to infinity) of Candesartan(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr)
- tmax(Time to reach the maximum concentration) of Candesartan(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr)
- CL/F(Clearance/Bioavailability) of Amlodipine(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr)
Investigators
Study Sites (1)
Loading locations...
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