A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Amlodipine plus Losartan; Drug: Amlodipine, Losartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01197014

10-ALOS-102

Details and patient eligibility

About

Study Design :

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

Full description

Primary Objective:

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

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

72 participants in 2 patient groups

Amlodipine plus Losartan

Experimental group

Treatment:

Drug: Amlodipine plus Losartan

Amlodipine, Losartan

Active Comparator group

Treatment:

Drug: Amlodipine, Losartan