Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

Pfizer40 enrolled

Overview

The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Falciparum Malaria

Interventions

Artesunate (Test)DRUG

Oral tablet, single dose, 1 x 100 mg

Artesunate (Comparator)DRUG

Oral tablet, single dose, 2 x 50 mg

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Singapore, Singapore, Singapore

Outcomes

Primary Outcomes

AUC and Cmax of active metabolite of artesunate

Time frame: 30-Aug-2009

Secondary Outcomes

Tolerability

Time frame: 30-Aug-2009

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.