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
Detailed Description
Primary Objective: \- To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus two co-administered products containing amlodipine and losartan
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 :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01197014
Start Date
September 1 2010
End Date
December 1 2010
Last Update
April 27 2011
Active Locations (1)
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1
CEPHA s.r.o.
Pilsen, Czechia