NCT00859807

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 21, 2010

Status Verified

April 1, 2010

Enrollment Period

1 month

First QC Date

March 6, 2009

Last Update Submit

April 20, 2010

Conditions

Falciparum Malaria

Keywords

Amodiaquine suspensionFlavoquine tabletsBioequivalence study

Outcome Measures

Primary Outcomes (1)

  • Cmax, AUCtlast and AUCinf for amodiaquine.

    end of study

Secondary Outcomes (1)

  • Cmax and AUC72 for DesethylAQ

    end of study

Study Arms (2)

Sequence 1 (19 subjects)

EXPERIMENTAL

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).

Drug: Flavoquine®, Camoquin® Suspension

Sequence 2 (19 subjects)

EXPERIMENTAL

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

Drug: Flavoquine®, Camoquin® Suspension

Interventions

Flavoquine®, Camoquin® SuspensionDRUG

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.

Also known as: amodiaquine
Sequence 1 (19 subjects)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Navi Mumbai, Maharashtra, 400709, India

Location

Related Links

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Amodiaquine

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 11, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

April 21, 2010

Record last verified: 2010-04

Locations

IN(1)