NCT00894660

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1

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

May 4, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 21, 2010

Status Verified

April 1, 2010

Enrollment Period

1 month

First QC Date

May 4, 2009

Last Update Submit

April 20, 2010

Conditions

Falciparum Malaria

Keywords

Bioequivalence, Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • AUC and Cmax of amodiaquine

    1 month

Secondary Outcomes (1)

  • Tolerability

    1 month

Study Arms (2)

Amodiaquine (Pfizer)

EXPERIMENTAL
Drug: Amodiaquine (Test)

Amodiaquine tablets (Arsuamoon-Guilin China)

ACTIVE COMPARATOR
Drug: Amodiaquine (Comparator)

Interventions

Amodiaquine (Test)DRUG

Oral tablet, single dose, 1 X 300 MG

Also known as: Camoquin
Amodiaquine (Pfizer)
Amodiaquine (Comparator)DRUG

Oral tablet, single dose, 2 X 150 MG

Also known as: Camoquin
Amodiaquine tablets (Arsuamoon-Guilin China)

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Evidence or history of clinically significant abnormalities.
  • A positive urine drug screen, history of regular alcohol consumption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, Singapore, 188770, Singapore

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 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 7, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

April 21, 2010

Record last verified: 2010-04

Locations

SG(1)