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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: April 2, 2009
Last updated: June 7, 2010
Last verified: June 2010
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).

Condition Intervention Phase
Healthy Volunteers
Drug: artesunate sachets
Drug: Arsuamoon
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Single-Dose Bioequivalence Study Comparing Artesunate Sachets (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Cmax, AUCinf and AUClast, for DHA [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Safety laboratory tests, vital signs, and adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: June 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.0 Drug: artesunate sachets
single dose 50 mg (2 X 25 mg) artesunate sachets
Active Comparator: 2.0 Drug: Arsuamoon
single dose 50 mg arsuamoon tablet


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00875030

Pfizer Investigational Site
Navi Mumbai, Maharashtra, India, 400709
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00875030     History of Changes
Other Study ID Numbers: B0551002 
Study First Received: April 2, 2009
Last Updated: June 7, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Pfizer:
Bioequivalence study-artesunate sachets-arsuamoon tablet

Additional relevant MeSH terms:
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 03, 2016