NCT05497063View on ClinicalTrials.gov

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

PHASE1UnknownINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

December 31, 2022

Primary Completion Date

February 28, 2023

Study Completion Date

February 28, 2023

Conditions
Bioequivalence
Interventions
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

Sponsors
All Listed Sponsors
lead

Emzor Pharmaceutical Industries Limited

INDUSTRY