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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cmax
Timeframe: Up to 36 hours post dose in each treatment period
. 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.
. Heavy smokers.
. Female subjects who were pregnant or nursing.
. Acute infection within one week preceding first study drug administration.