Healthy
Conditions
Brief 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)
Detailed description
Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the selection criteria. All dosed subject samples will be analyzed and their data will be included in the final study report. Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%. A comprehensive final report will be issued upon the completion of the study.
Interventions
DRUGJanumet 50/1000(Metformin HCl & Sitagliptin)
Reference drug
DRUGGleptomet 50/1000(Metformin HCl & Sitagliptin)
Test drug
Sponsors
Eva Pharma
Genuine Research Center, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Comparative, Randomized, Single Dose, Two-way Crossover Bioequivalence Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female, age 18 to 55 years, inclusive. 2. Body weight within 15% of normal range (18.5-30.0) according to the accepted normal values for body mass index (BMI). 3. 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. 4. Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator. 5. Females should be on a suitable birth control method. 6. Fully informed subjects that consented to participate in the study.
Exclusion criteria
1. Subjects with known allergy to the products tested. 2. Subjects who meet any of the contraindications to the administration of Sitagliptin and/or Metformin HCl. 3. Subjects who are going to get an injection of dye or contrast agents for an x-ray procedure. 4. 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. 5. 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. 6. Heavy smokers. 7. Female subjects who were pregnant or nursing. 8. Acute infection within one week preceding first study drug administration. 9. History of drug or alcohol abuse. 10. Subject does not comply with the stated instruction of not taking any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study. 11. Subject is on a special diet (for example subject is vegetarian). 12. Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period. 13. Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study. 14. Subject has a family history of severe diseases which have direct impact on the study. 15. Participation in a bioequivalence study or in a clinical study within the last 60 days, before first study drug administration. 16. Subject intends to be hospitalized within 3 months after first study drug administration. 17. Subjects who have blood donated or lost more than 500 mL blood within 3 months prior to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Up to 36 hours post dose in each treatment period | to measure the maximal measured plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | Up to 36 hours post dose in each treatment period | time of the maximum plasma concentration |
Countries
Egypt
Outcome results
None listed