A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
Phase 1
Completed
- Conditions
- Falciparum Malaria
- Interventions
- Registration Number
- NCT00894660
- Lead Sponsor
- Pfizer
- Brief Summary
The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
- Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
- BMI of 18 to 30 kg/m2; and a total body weight >45 kg (99 lbs).
- An informed consent document signed and dated by the subject or a legally acceptable representative.
Exclusion Criteria
- Evidence or history of clinically significant abnormalities.
- A positive urine drug screen, history of regular alcohol consumption.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Amodiaquine tablets (Arsuamoon-Guilin China) Amodiaquine (Comparator) - Amodiaquine (Pfizer) Amodiaquine (Test) -
- Primary Outcome Measures
Name Time Method AUC and Cmax of amodiaquine 1 month
- Secondary Outcome Measures
Name Time Method Tolerability 1 month
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie amodiaquine's antimalarial activity against Plasmodium falciparum heme polymerase in phase 1 trials?
How does the bioequivalence of Pfizer's amodiaquine compare to Arsuamoon-Guilin in terms of plasma concentration and efficacy against chloroquine-resistant P. falciparum strains?
Which pharmacogenetic biomarkers influence amodiaquine metabolism and treatment outcomes in P. falciparum malaria patients?
What are the potential adverse events associated with amodiaquine formulations in healthy volunteers, and how are they managed in phase 1 trials?
Are there synergistic effects of amodiaquine with artemisinin-based combination therapies (ACTs) for treating multidrug-resistant P. falciparum malaria?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇸🇬Singapore, Singapore