Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Amlodipine - reference; Drug: Amlodipine ODT - test

Study type: Interventional

Funder types: Industry

Identifiers

NCT01138826

051-10

A0531095

Details and patient eligibility

About

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 (non-ODT) tablet.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female 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 18 to 26 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

treatment A - reference w/ water

Active Comparator group

Treatment:

Drug: Amlodipine - reference

Treatment B - ODT (test) w/ water

Experimental group

Treatment:

Drug: Amlodipine ODT - test

Drug: Amlodipine ODT - test

Treatment C - ODT (test) w/o water

Experimental group

Treatment:

Drug: Amlodipine ODT - test

Drug: Amlodipine ODT - test