Safety and Pharmacokinetics Study of Amlodipine 10mg and Candesartan 32mg

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: candesartan cilexetil 32mg, amlodipine 10mg

• Registration Number: NCT01926652
• Lead Sponsor: Shin Poong Pharmaceutical Co. Ltd.

Brief Summary

Clinical trial to evaluate the pharmacokinetic interactions and safety between single dose of amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with candesartan 32mg in healthy male volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted: 2013-08-18
• Study First Submitted QC: 2013-08-20
• Last Update Submitted: 2013-08-20
• Study First Posted: 2013-08-21
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

1. Male volunteers in the age between 20 and 55 years old(inclusive).
2. Body weight >= 55kg and Body mass index (BMI) in the range of calculated IBW ±20%.
3. Subjects without a hereditary problems or chronic desease.
4. Subjects whose clinical laboratory test values are inside the accepted normal range.
5. Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria

1. Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines.
2. Systolic blood pressure range ≥150 mmHg or ≤ 100 mmHg or diastolic blood pressure range ≥ 95 mmHg or ≤ 60 mmHg.
3. Subject with symptoms of acute disease within 14days prior to study medication dosing.
4. Subjects with a history of clinically significant allergies of amlodipin or candesartan or CCB or other medicine (ex. aspirin or antibiotics).
5. Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
6. Serum creatinine > 1.2mg/dL.
7. smoking > 10 cigarettes/day.
8. alcohol > 210g/week.
9. Positive test results for drug test in urin or subject with history of substance abuse.
10. Participation in any clinical investigation within 2 months prior to study medication dosing.
11. Subjects with whole blood donation within 2 months, component blood donation within 1 month and blood transfusion within 1 month prior to study medication dosing.
12. Subjects considered as unsuitable based on medical judgement by investigators.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
candesartan	candesartan cilexetil 32mg, amlodipine 10mg	Single administration : candesartan cilexetil 32mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd
amlodipine	candesartan cilexetil 32mg, amlodipine 10mg	Single administration : amlodipine 10mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd

Primary Outcome Measures

Name	Time	Method
AUC, Cmax	7days, 10days

Secondary Outcome Measures

Name	Time	Method
Cmin, tmax, CL/F	7days, 10days

Trial Locations

Locations (1)

Chungnam national university hospital, clinical trial center; 🇰🇷 Daejeon, Chungcheongbul-do, Korea, Republic of