Clinical trial NCT06522763: Bioequivalence Study of Sulfadoxine/Pyrimethamine 500/25 mg Dispersible Tablet
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Fasting
Lead sponsor: Swiss Pharma Nigeria Limited
Sponsor class: INDUSTRY
Collaborators: name: Medicines for Malaria Venture
First posted: 2024-07-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximal Plasma Concentration (Cmax).
timeFrame: 72 hours
measure: Area Under the plasma concentration-time Curve (AUC).
timeFrame: 72 hours
Secondary outcomes:
measure: Time point of maximal plasma concentration (Tmax)
timeFrame: To be determined within the 72 hours range
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: International Pharmaceutical Research Center (IPRC) Queen Rania Street - Sport City Circle,
Study officials:
affiliation: International Pharmaceutical Research Center ( IPRC)
name: Majdi Abu Awida, Doctor
role: PRINCIPAL_INVESTIGATOR
References: