A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan
Information source: Hanmi Pharmaceutical Company Limited
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Amlodipine plus Losartan (Drug); Amlodipine, Losartan (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Hanmi Pharmaceutical Company Limited Overall contact:
Kyung-mi Park, Ph.D., Phone: 82-2-410-9270
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
Clinical Details
Official title: 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: Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: AUC, Cmax
Detailed description:
Secondary Objective:
- To evaluate the safety and tolerability of these formulations.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Kyung-mi Park, Ph.D., Phone: 82-2-410-9270
CEPHA s.r.o., Pilsen CZ-323 00, Czech Republic; Recruiting
Additional Information
Starting date: August 2010
Last updated: September 7, 2010
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