A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
NCT ID: NCT00859807
Last Updated: 2010-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
38 participants
INTERVENTIONAL
2009-05-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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).
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.
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
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Navi Mumbai, Maharashtra, India
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B0731001
Identifier Type: -
Identifier Source: org_study_id
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