Health TrialsbyHealthPanel

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

ConditionFasting
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorSwiss Pharma Nigeria Limited

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy subjects male or female (childbearing potential or surgically sterile female (confirmed by medical/operative report or if medical/operative report is not available by ultrasound test)), age 18 to 50 years, inclusive, for post-menopausal female aged between 45 and 65 years inclusive.

Body Mass Index (BMI) range8 is within 18.5 - 30.0 Kg/m2.

Subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs.

Medical history and physical examination within medically acceptable criteria.

Disqualifiers

Medical demographics performed not longer than two weeks before the initiation of the clinical study with significant deviations from the normal ranges

Presence of any clinically significant results from laboratory tests found in Annex I, however, ALP and creatinine will be accepted if below reference range after being evaluated by the physician as clinically not significant. Laboratory tests are performed not longer than two weeks before the initiation of the clinical study.

History of drug or alcohol abuse.

Subject is a heavy smoker (more than 10 cigarettes per day).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets.

    Drug

    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.

  • Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQ

    Drug

    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.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Test Product: 500/25mg Sulfadoxine / Pyrimethamine Dispersible tablets.Experimental treatment 1 intervention
Group B: Reference Product: SPAQ-CO® Dispersible tablets.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maximal Plasma Concentration (Cmax).

The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax are set to be within 80.00-125.00% for sulfadoxine and pyrimethamine. ANOVA using 5 % significance level on logarithmically transformed data (with the 90% confidence intervals) of Cmax and AUC0-72 for sulfadoxine and pyrimethamine using WinNonLin statistical software version 8.4 or higher.

Time frame
72 hours
2

Area Under the plasma concentration-time Curve (AUC).

The confidence intervals of logarithmically transformed Test/Reference ratios for AUC are set to be within 80.00-125.00% for sulfadoxine and pyrimethamine. ANOVA using 5 % significance level on logarithmically transformed data (with the 90% confidence intervals) of AUC0-72 for sulfadoxine and pyrimethamine using WinNonLin statistical software version 8.4 or higher.

Time frame
72 hours

Secondary outcomes

1

Time point of maximal plasma concentration (Tmax)

Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value.

Time frame
To be determined within the 72 hours range

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Swiss Pharma Nigeria Limited

Lead sponsor

Medicines for Malaria Venture

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: