Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 48
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 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. arm 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

Interventions: intervention 1: Amlodipine intervention 2: Amlodipine intervention 3: Amlodipine intervention 4: Amlodipine
Intervention descriptions: intervention 1: 3rd OD 5 mg tablet single oral dose administered with water intervention 2: 2nd OD 5 mg tablet single oral dose administered with water intervention 3: 3rd OD 5 mg tablet single oral dose administered without water intervention 4: 2nd OD 5 mg tablet single oral dose administered without water

Protocol document: