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A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00894660
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : April 21, 2010
Sponsor:
Information provided by:
Pfizer

Brief Summary:
The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China).

Condition or disease Intervention/treatment Phase
Falciparum Malaria Drug: Amodiaquine (Test) Drug: Amodiaquine (Comparator) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
Study Start Date : June 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Amodiaquine (Pfizer) Drug: Amodiaquine (Test)
Oral tablet, single dose, 1 X 300 MG
Other Name: Camoquin
Active Comparator: Amodiaquine tablets (Arsuamoon-Guilin China) Drug: Amodiaquine (Comparator)
Oral tablet, single dose, 2 X 150 MG
Other Name: Camoquin



Primary Outcome Measures :
  1. AUC and Cmax of amodiaquine [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Tolerability [ Time Frame: 1 month ]


Information from the National Library of Medicine

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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.

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): NCT00894660


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00894660     History of Changes
Other Study ID Numbers: B0731004
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: April 21, 2010
Last Verified: April 2010

Keywords provided by Pfizer:
Bioequivalence, Healthy Volunteers

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