Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: Candesartan32mg; Drug: Amlodipine10mg

• Registration Number: NCT01806311
• Lead Sponsor: HanAll BioPharma Co., Ltd.

Brief Summary

Clinical trial to evalate the pharmacokinetic interactions and safety between single dose of amlodipine10mg and candesartan32mg and combiation dose amlodipine10mg with candesartan32mg in healthy male volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-03-04
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-07
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-02
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

1. Healthy male, Age 20 to 45
2. Subject must be willing and able to provide written informed consent to the study.

Exclusion Criteria

1. History of any significant sickness, liver system, gall bladder system, kidney, nerve system, respiratory system, blood tumor, endocrine system, urinary system, mental disease, muscloskeletal system, immunity system, the ear, nose and throat system and cardiovascular system.
2. History of any significant gastrointestinal system and surgery of gastrointestinal.
3. History of any significant hypersensitivity to amlodipine, candesartan, aspirin, antibiotic.
4. Over 10 tobaccos a day.
5. Other condition which in the opinion of the investigator preclude endrollment into the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PartA: Candesartan, Candesartan + Amolodipine	Candesartan32mg	Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
PartB: Amlodipine, Amlodipine+Candesartan	Candesartan32mg	Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
PartB: Amlodipine, Amlodipine+Candesartan	Amlodipine10mg	Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally
PartA: Candesartan, Candesartan + Amolodipine	Amlodipine10mg	Candesartan : multiple dose 32mg administered orally Amlodipine : multiple dose 10mg administered orally

Primary Outcome Measures

Name	Time	Method
Part A : AUC, Cmax of Candesartan	Over a 24-hour sampling period
Par B : AUC, Cmax of Amlodipine	Over a 24-hour sampling period

Secondary Outcome Measures

Name	Time	Method
PartA: Cmin, tmax, CL/F of Candesartan	Over a 24-hour sampling period
PartB: Cmin, tmax, CL/F of Amlodipine	Over a 24-hour sampling period

Trial Locations

Locations (1)

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