Phase 1Completed

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

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. )

Sponsor
Genuine Research Center, Egypt (Industry)
Enrollment
27 enrolled
Conditions
Healthy
Interventions
Glibesyn; Daonil
Ages
adults
Registry
NCT03855306

Full record on ClinicalTrials.gov

From the registry

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

Primary outcomes

  • Maximal measured plasma concentration (Cmax)

History

  1. Registered

  2. Study completion

  3. Primary completion

  4. Started