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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 4

Conditions

Healthy Volunteers

Treatments

Drug: Arsuamoon
Drug: artesunate sachets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00875030
B0551002

Details and patient eligibility

About

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).

Enrollment

40 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

1.0
Experimental group
Treatment:
Drug: artesunate sachets
2.0
Active Comparator group
Treatment:
Drug: Arsuamoon

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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