A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
NCT00894660 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2010-04-21
Summary
The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China).
Conditions
- Falciparum Malaria
Interventions
- DRUG
-
Amodiaquine (Test)
Oral tablet, single dose, 1 X 300 MG
- DRUG
-
Amodiaquine (Comparator)
Oral tablet, single dose, 2 X 150 MG
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 21 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-06-30
- Primary Completion
- 2009-07-31
- Completion
- 2009-07-31
Countries
- Singapore
Study Locations
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