Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Amodiaquine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Amodiaquine (Pfizer) | EXPERIMENTAL | - |
| Amodiaquine tablets (Arsuamoon-Guilin China) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Amodiaquine (Test) | DRUG | Oral tablet, single dose, 1 X 300 MG |
| Amodiaquine (Comparator) | DRUG | Oral tablet, single dose, 2 X 150 MG |
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: *...
Amodiaquine is a small molecule drug being developed by Pfizer, Inc. for the treatment of Falciparum Malaria, a form of malaria caused by the Plasmodium falciparum parasite. It is currently in Phase 1 clinical development as an investigational therapy for this infectious disease indication.
Amodiaquine is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for the treatment of Falciparum Malaria.
Amodiaquine is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of Falciparum Malaria, with one completed Phase 1 clinical trial.
Amodiaquine has one completed clinical trial, NCT00894660, a Phase 1 bioequivalence study comparing Amodiaquine tablets from Pfizer to Amodiaquine tablets from Arsuamoon-Guilin China in healthy subjects. The trial enrolled 38 participants in Singapore and was active-controlled, though not randomized or double-blind.
Amodiaquine is not the same as Arsuamoon. Arsuamoon is a brand name for amodiaquine tablets manufactured by Guilin Pharmaceutical in China, which was used as a comparator in a bioequivalence study. Amodiaquine is the generic drug name, and Pfizer's version is being developed as a separate product.