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

NCT05497063 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-08-11

No results posted yet for this study

Summary

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

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 & Collaborators

  • Emzor Pharmaceutical Industries Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2023-02-28
Completion
2023-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05497063 on ClinicalTrials.gov