Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2009-12-31

Brief Summary

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This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

24 subjects (12 subjects per sequence) will receive treatment A) one 5 mg amlodipine 3rd OD tablet (test) with water and treatment B) one 5 mg amlodipine 2nd OD tablet (reference) with water.

Group Type EXPERIMENTAL

Amlodipine

Intervention Type DRUG

3rd OD 5 mg tablet single oral dose administered with water

Amlodipine

Intervention Type DRUG

2nd OD 5 mg tablet single oral dose administered with water

Cohort 2

24 subjects (12 subjects per sequence) will receive treatment C) one 5 mg amlodipine 3rd OD tablet (test) without water, and treatment D) one 5 mg amlodipine 2nd OD tablet (reference) without water

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

3rd OD 5 mg tablet single oral dose administered without water

Amlodipine

Intervention Type DRUG

2nd OD 5 mg tablet single oral dose administered without water

Interventions

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Amlodipine

3rd OD 5 mg tablet single oral dose administered with water

Intervention Type DRUG

Amlodipine

2nd OD 5 mg tablet single oral dose administered with water

Intervention Type DRUG

Amlodipine

3rd OD 5 mg tablet single oral dose administered without water

Intervention Type DRUG

Amlodipine

2nd OD 5 mg tablet single oral dose administered without water

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy;
* Body Mass Index (BMI) of 18 to 28 kg/m2;
* total body weight within the range of 50 to 100 kg

Exclusion Criteria

* History of regular alcohol consumption exceeding 14 drinks/week
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 10 cigarettes per day

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes