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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00894374
First Posted: May 7, 2009
Last Update Posted: June 25, 2010
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.
Information provided by:
Pfizer
  Purpose
The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).

Condition Intervention Phase
Falciparum Malaria Drug: Artesunate (Test) Drug: Artesunate (Comparator) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single-Dose Bioequivalence Study Comparing Artesunate Tablet (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUC and Cmax of active metabolite of artesunate [ Time Frame: 30-Aug-2009 ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: 30-Aug-2009 ]

Enrollment: 40
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Artesunate (Pfizer) Drug: Artesunate (Test)
Oral tablet, single dose, 1 x 100 mg
Active Comparator: Artesunate (Arsuamoon® Tablets Guilin-China) Drug: Artesunate (Comparator)
Oral tablet, single dose, 2 x 50 mg

  Eligibility

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.


Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00894374


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00894374     History of Changes
Other Study ID Numbers: B0551003
First Submitted: May 4, 2009
First Posted: May 7, 2009
Last Update Posted: June 25, 2010
Last Verified: June 2010

Keywords provided by Pfizer:
Bio-equivalence, Healthy Volunteers

Additional relevant MeSH terms:
Malaria, Falciparum
Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Artemisinins
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials