Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-06-30

Brief Summary

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This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate capsule.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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treatment A - reference w/ water

Group Type ACTIVE_COMPARATOR

Amlodipine - reference

Intervention Type DRUG

Amlodipine capsule, 10 mg, single dose, with water

Treatment B - ODT (test) w/o water

Group Type EXPERIMENTAL

Amlodipine ODT - test

Intervention Type DRUG

Amlodipine orally disintegrating tablet (ODT), 10 mg, single dose, without water

Interventions

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Amlodipine - reference

Amlodipine capsule, 10 mg, single dose, with water

Intervention Type DRUG

Amlodipine ODT - test

Amlodipine orally disintegrating tablet (ODT), 10 mg, single dose, without water

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female literate subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 26.4 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes