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

NCT04577469 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-10-08

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

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

Sponsors & Collaborators

  • Emzor Pharmaceutical Industries Limited

    lead INDUSTRY

Principal Investigators

  • Mohammed A Abu Fara, MD,Internist · ACDIMA Biocenter

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
2020-12-31
Primary Completion
2020-12-31
Completion
2020-12-31

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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 NCT04577469 on ClinicalTrials.gov