Safety and Pharmacokinetics Study of amlodipine10mg and candesartan32mg

An Open-label, Multiple-dose, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of amlodipine10mg and candesartan32mg in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01806311

Enrollment

Registered

2013-03-07

Start date

2012-12-31

Completion date

2013-08-31

Last updated

2025-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Pharmacokinetics, Safety, Male

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.

Interventions

DRUGCandesartan32mg

DRUGAmlodipine10mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026