Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Glibenclamide From Glibesyn 5 mg Tablets (Medochemie LTD Cyprus) and Daonil 5 mg Tablets (Sanofi-Aventis Cyprus Ltd. )
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Maximal measured plasma concentration (Cmax)
Study Overview
Brief Summary
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Glibenclamide from Glibesyn 5 mg tablets (Manufactured by Medochemie LTD Cyprus) and Daonil 5 mg tablets (Sanofi-Aventis Cyprus Ltd. ) after a single oral dose administration of each to healthy adults under fasting conditions
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male or female, age 18 to 55 years, inclusive.
- •Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
- •Medical demographics without evidence of clinically significant deviation from normal medical condition.
- •Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
- •Volunteer does not have allergy to the drugs under investigation.
Exclusion Criteria
- •Volunteers with known allergy to the products tested.
- •Volunteers whose values of BMI were outside the accepted normal ranges.
- •Female volunteers who were pregnant, nursing.
- •Medical demographics with evidence of clinically significant deviation from normal medical condition.
- •Results of laboratory tests which are clinically significant.
- •Acute infection within one week preceding first study drug administration.
- •History of drug or alcohol abuse.
- •Volunteer does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
- •Volunteer is on a special diet (for example volunteer is vegetarian).
- •Volunteer 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.
- •Volunteer 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.
- •Volunteer has a history of severe diseases which have direct impact on the study.
- •Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
- •Volunteer intends to be hospitalized within 3 months after first study drug administration.
- •Volunteers who, through completion of this study, would have donated more than 500 ml of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.
Arms & Interventions
A Test
Test drug (Glibesyn) 1 tablet contains 5 mg Glibenclamide
Intervention: Glibesyn (Drug)
B Reference
Reference drug (Daonil) 1 tablet contains 5 mg Glibenclamide
Intervention: Daonil (Drug)
Outcomes
Primary Outcomes
Maximal measured plasma concentration (Cmax)
Time Frame: 48 hours
Serial blood samples for determination of study drug will be collected pre-dose and at 0.00, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12 , 24 and 48 hours
Secondary Outcomes
- Time of the maximum plasma concentration (tmax)(48 hours)