Bioequivalence Study of of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt… (NCT05798715) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp & Dohme, The Netherlands)
Egypt30 participantsStarted 2022-11-29
Plain-language summary
Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study to determine the bioequivalence of Metformin HCl From Gleptomet 50/1000 mg F.C.Tablets (EVA Pharma, Egypt) and Janumet 50/1000 mg F.C.Tablets (Merck Sharp \& Dohme, The Netherlands)
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Healthy male or female, age 18 to 55 years, inclusive.
✓. Body weight within 15% of normal range (18.5-30.0) according to the accepted normal values for body mass index (BMI).
✓. Medical demographics without evidence of clinically significant deviation from normal medical condition, eg.: no history of heart, liver, kidney, gastrointestinal, nervous system, or metabolic abnormalities.
✓. Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
✓. Females should be on a suitable birth control method.
✓. Fully informed subjects that consented to participate in the study.
Exclusion criteria
✕. Subjects with known allergy to the products tested.
✕. Subjects who meet any of the contraindications to the administration of Sitagliptin and/or Metformin HCl.
✕. Subjects who are going to get an injection of dye or contrast agents for an x-ray procedure.
✕. Subject does not agree not to consume any medication or food which may affect CYP3A4 enzyme at least one week prior to first study drug administration until donating the last sample of the study.
✕. Subjects that do not agree not to consume alcohol-containing beverages and foods for 1 week before dosing and throughout the period of sample collection.
What they're measuring
1
Cmax
Timeframe: Up to 36 hours post dose in each treatment period