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
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
Treatments tested in this trial
- Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets.
- Sulfadoxine 500 MG / Pyrimethamine 25 MG dispersible tablets in SPAQ
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
Swiss Pharma Nigeria Limited
Lead sponsor
Medicines for Malaria Venture
Collaborator
Source ClinicalTrials.gov