NCT02816970

Bioequivalence Study of Vildagliptin From Gliptus 50 mg Tablet (EVA Pharma, Egypt) and Galvus 50 mg Tablet (NOVARTIS PHARMA, GERMANY)

Open Label, Randomized, Single Dose, Two-way Crossover Bioequivalence Study of Vildagliptin From Gliptus 50 mg Tablet (EVA Pharma, Egypt) and Galvus 50 mg Tablet (NOVARTIS PHARMA, GERMANY)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Genuine Research Center, Egypt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Vildagliptin from Gliptus 50 mg tablet (EVA pharma, Egypt) and Galvus 50 mg tablet (NOVARTIS PHARMA, GERMANY) in Healthy Human Volunteers Under Fasting Condition

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Vildagliptin	1 tablet contains 50 mg vildagliptin
DRUG	Vildagliptin	1 tablet contains 50 mg vildagliptin

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2016-06-29
• Last updated: 2016-06-29

Locations

1 site across 1 country: Egypt