NCT04577469

Bioequivalence Study of Sulfadoxine/ Pyrimethamine Tablets in Healthy Subjects Under Fasting Conditions

Randomized,One-period,Single Oral Dose,Open-label,Parallel,Bioequivalence Study to Compare 500mg Sulfadoxine/25mg Pyrimethamine Tablet Versus G-COSPE® Tablet (500mg Sulfadoxine/25mg Pyrimethamine) in Healthy Subjects Under Fasting Condition

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Emzor Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To asses bio equivalence between two (500 mg sulfadoxine / 25 mg pyrimethamine) formulation.

Detailed description

The aim of this study is to assess bioequivalence between a single dose from the test product, Sulfadoxine/ Pyrimethamine tablets (500 mg sulfadoxine / 25 mg pyrimethamine), manufactured by Ms. Emzor Pharmaceuticals Industries Ltd, Nigeria versus the reference product G-COSPE® tablets (500 mg sulfadoxine / 25 mg pyrimethamine) manufactured by Guilin Pharmaceutical Co. Ltd, China under fasting conditions and to monitor the safety of the subjects.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Maldox tablets	500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition
DRUG	G-COSPE® tablets	500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition

Timeline

• Start date: 2020-12-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2020-10-08
• Last updated: 2020-10-08