NCT05497063

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

Randomized, Single Oral Dose, Open-label, Single-period, Parallel Group, Bioequivalence Study to Compare Sulfadoxine/Pyrimethamine Two Dispersible Tablets (250 mg Sulfadoxine / 12.5 mg Pyrimethamine) Versus G-COSPE® One Tablet (500 mg Sulfadoxine / 25 mg Pyrimethamine) in Healthy Subjects Under Fasting Condition

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (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 two dispersible tablets (250 mg sulfadoxine / 12.5 mg pyrimethamine), manufactured by Emzor Pharmaceuticals Industries Ltd, Nigeria versus the reference product G-COSPE® one tablet (500 mg sulfadoxine / 25 mg pyrimethamine) manufactured by Guilin Pharmaceutical Co. Ltd, China.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Sulfadoxine/Pyrimethamine dispersible tablets, 250 mg sulfadoxine / 12.5 mg pyrimethamine & 500 mg sulfadoxine / 25 mg pyrimethamine	Two tablets of 250 mg sulfadoxine / 12.5 mg pyrimethamine or 500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition
DRUG	G-COSPE® tablets	One tablet of G-COSPE® tablets, 500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2022-08-11
• Last updated: 2022-08-11