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

An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Amlodipine 10mg and Candesartan 32mg in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01926652

Enrollment

Registered

2013-08-21

Start date

2013-07-31

Completion date

2013-08-31

Last updated

2013-08-21

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

Conditions

Healthy

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.

Interventions

DRUGcandesartan cilexetil 32mg, amlodipine 10mg

Part A: Treatment A (candesartan), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover. Part B: Treatment A (Amlodipine), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
AUC, Cmax	7days, 10days

Secondary

Measure	Time frame
Cmin, tmax, CL/F	7days, 10days

Countries

South Korea

Outcome results

None listed

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