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

NCT02548286 | Completed Phase 1

• 1 other identifier: 144BE15015
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension; Healthy male volunteer; Candesartan, Amlodipine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

Study Arms (2)

Candesartan and Amlodipine

ACTIVE COMPARATOR

Candesartan 8mg and Amlodipine 5mg, PO, 1day or 22day

Drug: Candesartan 8mg; Drug: Amlodipine 5mg

CKD-330

EXPERIMENTAL

CKD-330 8/5mg, PO, 1day or 22day

Drug: CKD-330 8/5mg

Interventions

Candesartan 8mg DRUG

PO, 1day or 22day

Candesartan and Amlodipine

Amlodipine 5mg DRUG

PO, 1day or 22day

Candesartan and Amlodipine

CKD-330 8/5mg DRUG

PO, 1day or 22day

CKD-330

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Drug abuse
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chungnam National University Hospital

Daejeon, Jung-gu, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

candesartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jang Hee Hong, MD, PhD

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: September 14, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

KR (1)