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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-06-30

Brief Summary

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The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg) Artesunate Sachet (Pfizer) versus 50 mg (1x50 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).

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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1.0

Group Type EXPERIMENTAL

artesunate sachets

Intervention Type DRUG

single dose 50 mg (2 X 25 mg) artesunate sachets

2.0

Group Type ACTIVE_COMPARATOR

Arsuamoon

Intervention Type DRUG

single dose 50 mg arsuamoon tablet

Interventions

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artesunate sachets

single dose 50 mg (2 X 25 mg) artesunate sachets

Intervention Type DRUG

Arsuamoon

single dose 50 mg arsuamoon tablet

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes