Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nifurtimox _Test · 1 trial · 1 indication
AUC:area under the concentration versus time curve from zero to infinity after single (first) dose
AUC(0-tlast): AUC from time 0 to the last data point \> LLOQ(lower limit of quantitation)
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
| Arm | Type | Description |
|---|---|---|
| Test Treatment + Reference Treatment | EXPERIMENTAL | Male and female subjects with Chagas' disease will be give treatment follow below Crossover Sequence: 1. Test treatment 2. Reference treatment |
| Reference Treatment + Test Treatment | EXPERIMENTAL | Male and female subjects with Chagas' disease will be give treatment follow below Crossover Sequence: 1. Reference treatment 2. Test treatment |
| Name | Type | Description |
|---|---|---|
| Nifurtimox (Lampit, BAYA2502)_Test | DRUG | Orally intake of 1 \*120mg new formulation tablet as test treatment |
| Nifurtimox (Lampit, BAYA2502)_Reference | DRUG | Orally intake of 1 \*120mg current clinical formulation tablet as reference treatment |
Inclusion Criteria: \- Male/female patient diagnosed with chronic Chagas' disease: Previous diagnosis of acute or chronic Chagas' disease by a health clinic prior to screening for the study. The diagnosis of chronic Chagas' disease may be made by clinical findings, supported by antibody titers if a...
Nifurtimox _Test is an investigational small molecule being studied for bioequivalence. It is being evaluated in a clinical trial to assess whether a new oral tablet formulation of nifurtimox is bioequivalent to a reference formulation. The study enrolled 24 participants in Argentina.
Nifurtimox _Test is being developed by Bayer AG, a company traded on the OTC market under the ticker BAYRY. Bayer is conducting clinical research on this small molecule drug candidate for bioequivalence assessment.
Nifurtimox _Test is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 study has been completed, with no active trials currently ongoing.
Nifurtimox _Test has one completed clinical trial, NCT03708133, titled 'Study to Assess Bioequivalence of a New Nifurtimox Oral Tablet Formulation.' This Phase 1 study enrolled 24 participants in Argentina and evaluated the bioequivalence of the new tablet formulation.
Nifurtimox _Test is a test formulation of nifurtimox, an antiparasitic drug. The clinical trial NCT03708133 was designed to compare a new oral tablet formulation of nifurtimox against a reference formulation to assess bioequivalence.