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

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: CKD-330 8/5mg; Drug: Candesartan 8mg; Drug: Amlodipine 5mg

• Registration Number: NCT02548286
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Primary Completion: 2015-08
• Study First Submitted: 2015-08-20
• Study Completion: 2015-09
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-14
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CKD-330	CKD-330 8/5mg	CKD-330 8/5mg, PO, 1day or 22day
Candesartan and Amlodipine	Candesartan 8mg	Candesartan 8mg and Amlodipine 5mg, PO, 1day or 22day
Candesartan and Amlodipine	Amlodipine 5mg	Candesartan 8mg and Amlodipine 5mg, PO, 1day or 22day

Primary Outcome Measures

Name	Time	Method
AUCt(Area Under the Plasma Concentration-time curve) of Candesartan	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	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	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	0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chungnam National University Hospital; 🇰🇷 Daejeon, Jung-gu, Korea, Republic of