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Amodiaquine

Phase 4

Falciparum Malaria | Small molecule | Infectious Disease |Pfizer, Inc.|Trials Updated: Apr 21, 2010

Amodiaquine development status

Highest phase Phase 4 run by Sanofi (NCT00445796)
Phase scored for PFEPhase 1
Registered trials 5 across 3 sponsors since May 2006

Amodiaquine target and mechanism

ModalitySmall molecule

Also known as Amodiaquine (Test)

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Amodiaquine clinical trials

Amodiaquine · 1 trial · 1 indication

Phase 1 1
NCT00894660A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy SubjectsFalciparum Malaria
COMPLETED38 Analytics
PHASE1COMPLETED
A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
Falciparum MalariaUnlock trial analytics

Study Endpoints

Primary Endpoints

AUC and Cmax of amodiaquine
1 month

Secondary Endpoints

Tolerability
1 month
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Amodiaquine (Pfizer)EXPERIMENTAL -
Amodiaquine tablets (Arsuamoon-Guilin China)ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Amodiaquine (Test)DRUGOral tablet, single dose, 1 X 300 MG
Amodiaquine (Comparator)DRUGOral tablet, single dose, 2 X 150 MG
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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: *...

Countries:Singapore
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Frequently asked questions about Amodiaquine

What is Amodiaquine used for?

Amodiaquine is being studied for the treatment of Falciparum Malaria, an infectious disease caused by the Plasmodium falciparum parasite. It is a small molecule therapeutic candidate. The clinical program is focused on this specific malaria indication.

Who is developing Amodiaquine?

Amodiaquine is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the sponsor of the clinical program for this asset.

What phase is Amodiaquine in?

Amodiaquine is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes one completed trial.

What clinical trials is Amodiaquine in?

Amodiaquine has been evaluated in one completed Phase 1 trial, NCT00894660, titled a bioequivalence study comparing Amodiaquine tablet (Pfizer) to Amodiaquine tablets (Arsuamoon-Guilin China) in healthy subjects. The trial enrolled 38 participants in Singapore and was active-controlled.

Is Amodiaquine the same as Amodiaquine (Test)?

Yes, Amodiaquine is also known as Amodiaquine (Test). Both names refer to the same investigational drug candidate being developed by Pfizer for Falciparum Malaria.