NCT01197001CompletedPhase 1
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
Hanmi Pharmaceutical Company Limited1 site in 1 country72 target enrollmentStarted: August 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- AUC, Cmax
Study Overview
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 formulation of amlodipine/losartan versus two co-administered products containing amlodipine and losartan
Detailed Description
Secondary Objective:
- To evaluate the safety and tolerability of these formulations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 Criteria
- Not provided
Arms & Interventions
Amlodipine plus Losartan
Experimental
Intervention: Amlodipine plus Losartan (Drug)
Amlodipine, Losartan
Active Comparator
Intervention: Amlodipine, Losartan (Drug)
Outcomes
Primary Outcomes
AUC, Cmax
Time Frame: 0-144hrs
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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