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Bioequivalence Study of Sulfadoxine/Pyrimethamine 500/25 mg Dispersible Tablet

NCT06522763 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-07-26

No results posted yet for this study

Summary

The primary objective of this study is to assess the bioequivalence between the test product and the reference product based on Cmax and AUC0-\>72 for sulfadoxine and pyrimethamine in healthy adults under fasting conditions. The secondary objectives of present study are to describe the Tmax and assess the safety and tolerability profile of both test and reference products.

Conditions

  • Fasting

Interventions

DRUG

Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets.

The 500/25 mg sulfadoxine/pyrimethamine tablet will be dispersed in approximately 10 mL of water in a cup, the mixture obtained will be shaken thoroughly and given immediately to the subject to drink the contents, then the cup will be rinsed with additional approximately 10 mL of water and have the subject drink the contents to assure that the whole dose is taken.

DRUG

Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQ

The 500/25 mg sulfadoxine/pyrimethamine tablet will be dispersed in approximately 10 mL of water in a cup, the mixture obtained will be shaken thoroughly and given immediately to the subject to drink the contents, then the cup will be rinsed with additional approximately 10 mL of water and have the subject drink the contents to assure that the whole dose is taken.

Sponsors & Collaborators

  • Medicines for Malaria Venture

    collaborator OTHER

  • Swiss Pharma Nigeria Limited

    lead INDUSTRY

Principal Investigators

  • Majdi Abu Awida, Doctor · International Pharmaceutical Research Center ( IPRC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2024-08-31
Completion
2024-09-30

Countries

  • Jordan

Study Locations

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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 NCT06522763 on ClinicalTrials.gov