A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study of Amlodipine and Losartan Versus Two Co-administration of Amlodipine and Losartan in Healthy Caucasian Subjects

Study Design :

• A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study

Primary Objective:

• To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus two co-administered products containing amlodipine and losartan

Secondary Objective:

• To evaluate the safety and tolerability of these formulations.

Inclusion Criteria:

• Age 18-55 years
• Healthy Caucasian volunteers
• Non smokers or mild smokers

Exclusion criteria:

• Pregnancy and/or breast-feeding
• Participation in another clinical trial within 60 days prior to Period 1.