NCT06522763

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Swiss Pharma Nigeria Limited · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fasting

Interventions

Type	Name	Description
DRUG	Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets.	The 500/25 mg sulfadoxine/pyrimethamine tablet will be dispersed in approximately 10 mL of water in a cup, the mixture obtained will be shaken thoroughly and given immediately to the subject to drink the contents, then the cup will be rinsed with additional approximately 10 mL of water and have the subject drink the contents to assure that the whole dose is taken.
DRUG	Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQ	The 500/25 mg sulfadoxine/pyrimethamine tablet will be dispersed in approximately 10 mL of water in a cup, the mixture obtained will be shaken thoroughly and given immediately to the subject to drink the contents, then the cup will be rinsed with additional approximately 10 mL of water and have the subject drink the contents to assure that the whole dose is taken.

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-08-01
• Completion: 2024-09-01
• First posted: 2024-07-26
• Last updated: 2024-07-26

Locations

1 site across 1 country: Jordan