A Study Comparing Blood Levels After Single-Dose Administration Of Artesunate Sachets (Pfizer) Versus Single-Dose Administration Of Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
Overview
The primary objective of the study is to determine bioequivalence of 50 mg (2×25 mg) Artesunate Sachet (Pfizer) versus 50 mg (1×50 mg) tablet, Arsuamoon® (Guilin China) which is the World Health Organization Reference standard for artesunate The secondary objective is to assess the safety of Artesunate Sachet (Pfizer) and Arsuamoon® tablet (Guilin China).
Full Title of Study: “A Single-Dose Bioequivalence Study Comparing Artesunate Sachets (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Study Primary Completion Date: June 2009
Interventions
- Drug: artesunate sachets
- single dose 50 mg (2 X 25 mg) artesunate sachets
- Drug: Arsuamoon
- single dose 50 mg arsuamoon tablet
Arms, Groups and Cohorts
- Experimental: 1.0
- Active Comparator: 2.0
Clinical Trial Outcome Measures
Primary Measures
- Cmax, AUCinf and AUClast, for DHA
- Time Frame: 1 year
Secondary Measures
- Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate.
- Time Frame: 1 year
- Safety laboratory tests, vital signs, and adverse events.
- Time Frame: 1 year
Participating in This Clinical Trial
Inclusion Criteria
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. – Body Mass Index (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:
- Any condition possibly affecting drug absorption. – A positive urine drug screen. – Have a known history of hypersensitivity, allergy (except for untreated, asymptomatic, seasonal allergies at the time of dosing), severe adverse drug reaction, or intolerance to artesunate or its derivatives.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Pfizer
- Provider of Information About this Clinical Study
- Director, Clinical Trial Disclosure Group, Pfizer, Inc.
- Overall Official(s)
- Pfizer CT.gov Call Center, Study Director, Pfizer
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.