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Trial record 1 of 1 for:    NCT00894660
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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

Tracking Information
First Submitted Date  ICMJE May 4, 2009
First Posted Date  ICMJE May 7, 2009
Last Update Posted Date April 21, 2010
Study Start Date  ICMJE June 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
AUC and Cmax of amodiaquine [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2009)
AUC and Cmax of amodiaquine [ Time Frame: 30-Sept-2009 ]
Change History Complete list of historical versions of study NCT00894660 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
Tolerability [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2009)
Adverse Events [ Time Frame: 30-Sept-2009 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
Official Title  ICMJE A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
Brief Summary The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Falciparum Malaria
Intervention  ICMJE
  • Drug: Amodiaquine (Test)
    Oral tablet, single dose, 1 X 300 MG
    Other Name: Camoquin
  • Drug: Amodiaquine (Comparator)
    Oral tablet, single dose, 2 X 150 MG
    Other Name: Camoquin
Study Arms  ICMJE
  • Experimental: Amodiaquine (Pfizer)
    Intervention: Drug: Amodiaquine (Test)
  • Active Comparator: Amodiaquine tablets (Arsuamoon-Guilin China)
    Intervention: Drug: Amodiaquine (Comparator)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2009)
38
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00894660
Other Study ID Numbers  ICMJE B0731004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP