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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00894374
First received: May 4, 2009
Last updated: June 24, 2010
Last verified: June 2010
History of Changes
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • AUC and Cmax of active metabolite of artesunate [ Time Frame: 30-Aug-2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: 30-Aug-2009 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00894374     History of Changes
Other Study ID Numbers: B0551003
Study First Received: May 4, 2009
Last Updated: June 24, 2010
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Pfizer:
Bio-equivalence, Healthy Volunteers

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

ClinicalTrials.gov processed this record on May 22, 2013