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CompletedNCT00894660Updated Apr 21, 2010

A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects

A Phase 1 interventional study of Amodiaquine (Test) and Amodiaquine (Comparator) in Falciparum Malaria, sponsored by Pfizer. Completed at 1 site in Singapore. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-04-21.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Non-randomized
Ages
21 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Falciparum Malaria

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Keywords

  • Bioequivalence, Healthy Volunteers
03

In context

Malaria, Falciparum

384 studies on the registry are indexed under Malaria, Falciparum; 38 are open to participants now.

This study's enrollment of 38 is below the median of 132 across 319 interventional studies indexed under Malaria, Falciparum.

Browse Malaria, Falciparum studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Evidence or history of clinically significant abnormalities.
  • A positive urine drug screen, history of regular alcohol consumption.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Amodiaquine (Pfizer)

    Drug: Amodiaquine (Test)

  • Active comparator
    Amodiaquine tablets (Arsuamoon-Guilin China)

    Drug: Amodiaquine (Comparator)

Interventions

  • DrugAmodiaquine (Test)

    Oral tablet, single dose, 1 X 300 MG

    Also known as: Camoquin

  • DrugAmodiaquine (Comparator)

    Oral tablet, single dose, 2 X 150 MG

    Also known as: Camoquin

06

What researchers measure

Primary outcomes

  1. AUC and Cmax of amodiaquine

    Time frame: 1 month

Secondary outcomes

  1. Tolerability

    Time frame: 1 month

07

Study locations

1 site
  • Pfizer Investigational Site
    Singapore, 188770, Singapore
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00894660
Lead sponsor
Pfizer
First posted
May 7, 2009
Start date
Jun 2009
Primary completion
Jul 2009
Completion
Jul 2009
Last update
Apr 21, 2010

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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