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

NCT01926652 | Completed Phase 1 DMC

• 1 other identifier: SP-AC-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• AUC, Cmax

  7days, 10days

Secondary Outcomes (1)

• Cmin, tmax, CL/F

  7days, 10days

Study Arms (2)

candesartan

EXPERIMENTAL

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

Drug: candesartan cilexetil 32mg, amlodipine 10mg

amlodipine

EXPERIMENTAL

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

Drug: candesartan cilexetil 32mg, amlodipine 10mg

Interventions

candesartan cilexetil 32mg, amlodipine 10mg DRUG

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.

Also known as: atacand 32mg, norvasc 10mg

amlodipine; candesartan

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shin Poong Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Chungnam national university hospital, clinical trial center

Daejeon, Chungcheongbul-do, 301-721, South Korea

Location

MeSH Terms

Interventions

candesartan cilexetil; Amlodipine

Intervention Hierarchy (Ancestors)

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

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 18, 2013
• First Posted: August 21, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 21, 2013

Record last verified: 2013-08

Locations

KR (1)