A Bioequivalence Study of Glibenclamide From Glibesyn 5 mg Tablets (Medochemie LTD Cyprus) and Daonil 5 mg Tablets (Sanofi-Aventis Cyprus Ltd. )

NCT03855306 | Completed Phase 1

• 1 other identifier: GRC/1/18/17Gliben
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Maximal measured plasma concentration (Cmax)

  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

  48 hours

Secondary Outcomes (1)

• Time of the maximum plasma concentration (tmax)

  48 hours

Study Arms (2)

A Test

EXPERIMENTAL

Test drug (Glibesyn) 1 tablet contains 5 mg Glibenclamide

Drug: Glibesyn

B Reference

ACTIVE COMPARATOR

Reference drug (Daonil) 1 tablet contains 5 mg Glibenclamide

Drug: Daonil

Interventions

Glibesyn DRUG

1 tablet contains 5 mg Glibenclamide

Also known as: Glibenclamide

A Test

Daonil DRUG

1 tablet contains 5 mg Glibenclamide

Also known as: Glibenclamide

B Reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy male or female, age 18 to 55 years, inclusive. 2. 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.

You may not qualify if:

• \. Volunteers with known allergy to the products tested. 2. Volunteers whose values of BMI were outside the accepted normal ranges. 3. Female volunteers who were pregnant, nursing. 4. Medical demographics with evidence of clinically significant deviation from normal medical condition.
• \. Results of laboratory tests which are clinically significant. 6. Acute infection within one week preceding first study drug administration. 7. History of drug or alcohol abuse. 8. 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). 10. 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.

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• Medochemie LTD Cyprus: collaborator

Study Sites (1)

Genuine Research Center GRC

Cairo, 11757, Egypt

Location

Related Publications (3)

• Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.

  PMID: 11381568 BACKGROUND

• Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.

  PMID: 2004861 BACKGROUND

• Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

  PMID: 3450848 BACKGROUND

MeSH Terms

Interventions

Glyburide

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Ahmed Elshafeey, Ph.D. Pharma

  Genuine Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: February 26, 2019
• Study Start: June 30, 2018
• Primary Completion: July 7, 2018
• Study Completion: August 15, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

EG (1)