Comparison of the effect of three Benznidazole formulations for the treatment of Chagas Disease

Comparative bioavailability study of three Benznidazole formulations after ingestion of a specific meal - STPh 02/22

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-6zfzs4j

Enrollment

Unknown

Registered

2025-09-30

Start date

2022-10-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BMI-Age

Interventions

The in vivo study will be a randomized, open-label, single-center, crossover clinical trial using three 100 mg BZN tablet formulations: Lafepe, designated as the test formulation (T)

Elea, designated as reference formulation one (R1)

and Liconsa, designated as reference formulation two (R2). The same batches evaluated in the pharmaceutical equivalence test were used. Treatments will be administered as a single 100 mg dose in three

D27.505.954.122.250

Eligibility

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers; both genders; aged 18 to 50 years; body mass index between 19 and 30 kg/m²; willing to use condoms during the study and up to 7 days after the last dose of the medication; able to understand the nature and purpose of the study, including risks and adverse events

Exclusion criteria

Exclusion criteria: Pregnancy; breastfeeding; smoking; history of alcohol or drug abuse

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: It is expected to demonstrate the interchangeability among the three benznidazole formulations available nationally and internationally, through relevant pharmacokinetic parameters, such as maximum plasma concentration (Cmax) and time to reach Cmax (Tmax);Found outcome 1: The bioequivalence condition was verified by comparing the bioavailability parameters (Cmax, Tmax and AUC) among the three drug formulations, which were found to be bioequivalent to each other	—

Measure

Time frame

Expected outcome 1: It is expected to demonstrate the interchangeability among the three benznidazole formulations available nationally and internationally, through relevant pharmacokinetic parameters, such as maximum plasma concentration (Cmax) and time to reach Cmax (Tmax);Found outcome 1: The bioequivalence condition was verified by comparing the bioavailability parameters (Cmax, Tmax and AUC) among the three drug formulations, which were found to be bioequivalent to each other

—

Secondary

Measure	Time frame
Expected outcome 2: Adverse events related to benznidazole are expected to be identified;Found outcome 2: thirty-three adverse events were recorded classified as mild (94%) or moderate (6%) and not serious; twenty-one (64%) were evaluated as having some degree of causality related to the use of benznidazol	—

Countries

Brazil

Contacts

Public ContactAndréa Sousa

Fundação Oswaldo Cruz

andrea.silvestre@ini.fiocruz.br+55-21-38659506

Outcome results

None listed

Source: REBEC (via WHO ICTRP)