A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects

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NCT00859807

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Study Location
Pfizer Investigational Site
Navi Mumbai, Maharashtra, 400709, India
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Falciparum Malaria
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- A history of drug induced agranulocytosis and history of liver and hematological
problems while taking amodiaquine.


- Any condition possibly affecting drug absorption (eg, gastrectomy).


- A positive urine drug screen.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
Official Title  ICMJE A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
Brief Summary The purpose of this study is to determine bioequivalence of amodiaquine suspension ( Pfizer) and the WHO approved reference product Flavoquine® tablet ( Sanofi Aventis).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Falciparum Malaria
Intervention  ICMJE Drug: Flavoquine®, Camoquin® Suspension
Treatment A 15.3 mL (50 mg/5 mL) AQ suspension single dose. Treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis) single dose.
Other Name: amodiaquine
Study Arms  ICMJE
  • Experimental: Sequence 1 (19 subjects)

    Period 1: treatment A (15.3 mL (50 mg/5 mL) AQ suspension (Pfizer); test treatment.

    Period 2: treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis); reference treatment).

    Intervention: Drug: Flavoquine®, Camoquin® Suspension
  • Experimental: Sequence 2 (19 subjects)
    Period 1: treatment B (1 x 200 mg tablet Flavoquine® (Sanofi Aventis Period 2: treatment A (15.3 mL (50 mg/5 mL) AQ suspension (Pfizer); test treatment
    Intervention: Drug: Flavoquine®, Camoquin® Suspension
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: March 10, 2009)		38
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • A history of drug induced agranulocytosis and history of liver and hematological problems while taking amodiaquine.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00859807
Other Study ID Numbers  ICMJE B0731001
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 CenterPfizer
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