clinical trial · NCT06522763
Bioequivalence Study of Sulfadoxine/Pyrimethamine 500/25 mg Dispersible Tablet
Swiss Pharma Nigeria Limited·phase1·not yet recruiting·n = 46
FastingSulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets.Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQ
brief 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.
started
Jul 1, 2024
primary completion
Aug 1, 2024
completion
Sep 1, 2024
last updated
Jul 26, 2024
official title
Comparative Randomized, Single Dose, Two-Arm, Parallel Open Label Study to Determine the Bioequivalence of Sulfadoxine/Pyrimethamine 500/25 mg Dispersible Tablet After an Oral Administration to Healthy Adults Under Fasting Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol