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

Comparative Randomized, Single Dose, Two-Arm, Parallel Open Label Study to Determine the Bioequivalence of Sulfadoxine/Pyrimethamine 500/25 mg Dispersible Tablet After an Oral Administration to Healthy Adults Under Fasting Conditions

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fasting
• Intervention / Treatment: Drug: Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets.; Drug: Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQ

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yetunde Adigun, B.Pharm; Phone Number: +2349055990983; Email: yetunde.adigun@swiphanigeria.com
• Study Contact Backup: Name: Ismail Olaoye, IT; Phone Number: +2349055990922; Email: ismail.olaoye@swiphanigeria.com

Study Locations

• Jordan
  • Amman, Jordan, 11196
    • International Pharmaceutical Research Center (IPRC) Queen Rania Street - Sport City Circle,
    • Contact: Omaima Omaima Najib, Doctor; Phone Number: +96265627651; Email: o.najib@iprc.com.jo
    • Contact: Nourhan Alramad, Data Analyst; Phone Number: +96265627651; Email: dm@iprc.com.jo
    • Principal Investigator: Majdi Abu Awida, Doctor
    • Sub-Investigator: Usuma Harb, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. Body Mass Index (BMI) range8 is within 18.5 - 30.0 Kg/m2.
3. Subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs.
4. Medical history and physical examination within medically acceptable criteria.
5. Subjects having QTc value less than 450 msec for male or less than 440 msec for female at the time of screening.
6. Negative pregnancy test or post-menopausal (ie, at least 1 year without menses and without an alternative medical condition prior to the Screening visit, confirmed by FSH test) if female.
7. Laboratory investigations tests within laboratory reference ranges found in Annex I (ALP and creatinine are accepted if below the reference range after being evaluated by the physician as clinically not significant).
8. Subject is capable of consent.
9. Female subjects of childbearing potential and agrees to use total abstinence or an acceptable contraceptive method of the following: - Systemic contraceptives (birth control pills, injectable/ implantable/ insertable hormonal birth control products, transdermal patch) - Intrauterine device - Condom with intravaginal spermicide

Exclusion Criteria:

1. Medical demographics performed not longer than two weeks before the initiation of the clinical study with significant deviations from the normal ranges
2. 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.
3. History of drug or alcohol abuse.
4. Subject is a heavy smoker (more than 10 cigarettes per day).
5. Subject does not agree to not taking any prescription or non-prescription drugs within at least two weeks before study drug administration and until donating the last sample of the study.
6. Subject does not agree to not taking any vitamins taken for nutritional purposes within at least two days before study drug administration and until donating the last sample of the study.
7. Subject is on a special diet (for example subject is vegetarian).
8. Subject consumes large quantities of alcohol or beverages containing methylxanthines e.g. caffeine (coffee, tea, cola, energy drinks, chocolate etc.).
9. Subject does not agree to not consuming any beverages or food containing alcohol at least 48 hours prior to study drug administration until donating the last sample of the study.
10. Subject does not agree to not consuming any beverages or food containing methylxanthines e.g. caffeine (coffee, tea, cola, energy drinks, chocolate etc.) at least 24 hours prior to the study drug administration until the end of confinement.
11. Subject does not agree to not consuming any beverages or food containing grapefruit at least 7 days prior to study drug administration until donating the last sample of the study.
12. Subject has a history of severe diseases, which have direct impact on the study.
13. Participation in a bioequivalence study or in a clinical study within the last 90 days before study drug.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Product: 500/25mg Sulfadoxine / Pyrimethamine Dispersible tablets.; A single oral dose of 500/25 mg sulfadoxine/pyrimethamine dispersible tablets will be administered.	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.
Active Comparator: Reference Product: SPAQ-CO® Dispersible tablets.; A single oral dose of 500/25 mg sulfadoxine/pyrimethamine dispersible tablet from the SPAQ-CO® will be administered.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours
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.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	To be determined within the 72 hours range

Collaborators and Investigators

• Sponsor: Swiss Pharma Nigeria Limited
• Collaborators: Medicines for Malaria Venture
• Investigators: Principal Investigator: Majdi Abu Awida, Doctor, International Pharmaceutical Research Center ( IPRC)

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Anti-Infective Agents, Urinary; Pyrimethamine; Sulfadoxine
• Other Study ID Numbers: SUPY-T005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The access is controlled, with access only after written approval from IPRC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No