Status:
COMPLETED
A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 formu...
Detailed Description
Secondary Objective: * To evaluate the safety and tolerability of these formulations.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01197001
Start Date
August 1 2010
End Date
November 1 2010
Last Update
April 27 2011
Active Locations (1)
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1
CEPHA s.r.o.
Pilsen, Czechia, CZ-323 00