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

Launched by SWISS PHARMA NIGERIA LIMITED · Jul 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of medication called sulfadoxine/pyrimethamine, which comes in a 500/25 mg dispersible tablet form. The main goal is to see how well this new version of the medication works compared to an existing version when taken by healthy adults who have not eaten beforehand. Researchers will measure how quickly and effectively the medication is absorbed in the body and will also look at how safe and tolerable both versions of the medication are.

To participate in this study, you need to be a healthy adult between the ages of 18 and 50, or a post-menopausal woman aged 45 to 65. You should have a normal body weight and not have any allergies to the medication or related drugs. Participants will be asked to avoid certain foods, drinks, and medications for a period before and during the study. If you join the trial, you'll receive the medication and undergo some tests to monitor your health and the effects of the drug. This study is not yet recruiting participants, but it could be a valuable opportunity to help researchers learn more about this medication.

Gender

ALL

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.