Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

Viatris

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01004614

A0531088

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: Amlodipine

Drug: Amlodipine

Drug: Amlodipine

Drug: Amlodipine

Cohort 2

Active Comparator group

Description:

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

Treatment:

Drug: Amlodipine

Drug: Amlodipine

Drug: Amlodipine

Drug: Amlodipine