Status: Not yet recruiting
Bioequivalence Study of Sulfadoxine/Pyrimethamine 500/25 mg Dispersible Tablet
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.
Participants needed: 46
Trial details
Phase: Phase 1Age: 18-50Biological sex: AllType: InterventionalSponsor: Swiss Pharma Nigeria LimitedUpdated: Jul 26, 2024Locations: 1
Eligibility criteria
Healthy subjects male or female (childbearing potential or surgically sterile fe... [+8]
Medical demographics performed not longer than two weeks before the initiation o... [+12]