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

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)

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 Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Candesartan 8mg; Drug: Amlodipine 5mg; Drug: CKD-330 8/5mg

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jung-gu
    • Daejeon, Jung-gu, Korea, Republic of
      • Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Candesartan and Amlodipine; Candesartan 8mg and Amlodipine 5mg, PO, 1day or 22day	Drug: Candesartan 8mg; PO, 1day or 22day; Drug: Amlodipine 5mg; PO, 1day or 22day
Experimental: CKD-330; CKD-330 8/5mg, PO, 1day or 22day	Drug: CKD-330 8/5mg; PO, 1day or 22day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 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
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

Outcome Measure	Time Frame
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
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
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 Amlodipine	0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: August 20, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Estimate): December 7, 2015
• Last Update Submitted That Met QC Criteria: December 4, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Hypertension; Healthy male volunteer; Candesartan, Amlodipine
• 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: 144BE15015