Overview

Bioequivalence Study of Sulfadoxine/Pyrimethamine 500/25 mg Dispersible Tablet

Status:
NOT_YET_RECRUITING
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to assess the bioequivalence between the test product and the reference product based on Cmax and AUC0-\>72 for sulfadoxine and pyrimethamine in healthy adults under fasting conditions. The secondary objectives of present study are to describe the Tmax and assess the safety and tolerability profile of both test and reference products.
Phase:
PHASE1
Details
Lead Sponsor:
Swiss Pharma Nigeria Limited
Collaborator:
Medicines for Malaria Venture
Treatments:
Pyrimethamine
Sulfadoxine