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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: candesartan cilexetil 32mg, amlodipine 10mg

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chungcheongbul-do
    • Daejeon, Chungcheongbul-do, Korea, Republic of, 301-721
      • Chungnam national university hospital, Clinical trial center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: candesartan; Single administration : candesartan cilexetil 32mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd	Drug: candesartan 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.; Other Names: atacand 32mg, norvasc 10mg
Experimental: amlodipine; Single administration : amlodipine 10mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd	Drug: candesartan 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.; Other Names: atacand 32mg, norvasc 10mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC, Cmax	7days, 10days

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmin, tmax, CL/F	7days, 10days

Collaborators and Investigators

• Sponsor: Shin Poong Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 18, 2013
• First Submitted That Met QC Criteria: August 20, 2013
• First Posted (Estimate): August 21, 2013

Study Record Updates

• Last Update Posted (Estimate): August 21, 2013
• Last Update Submitted That Met QC Criteria: August 20, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Candesartan; Candesartan cilexetil
• Other Study ID Numbers: SP-AC-001