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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00875030
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : June 9, 2010
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteers Drug: artesunate sachets Drug: Arsuamoon Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Single-Dose Bioequivalence Study Comparing Artesunate Sachets (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
Study Start Date : June 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Cmax, AUCinf and AUClast, for DHA [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate. [ Time Frame: 1 year ]
  2. Safety laboratory tests, vital signs, and adverse events. [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00875030

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Pfizer Investigational Site
Navi Mumbai, Maharashtra, India, 400709
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00875030     History of Changes
Other Study ID Numbers: B0551002
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: June 9, 2010
Last Verified: June 2010
Keywords provided by Pfizer:
Bioequivalence study-artesunate sachets-arsuamoon tablet
Additional relevant MeSH terms:
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Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antiplatyhelmintic Agents