The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 14 days washout period between the doses.
This protocol describes an open labelled, single-dose, randomized, two-period, two-treatment, two-sequence crossover study to investigate the bioequivalence of two formulations of Vildagliptin and Metformin tablets 50/1000 mg manufactured by Mylan Laboratories Limited, India to GALVUS MET (50mg/1000 mg) tablets manufactured by NOVARTIS PHARMA PRODUKTIONS GmbH, Germany. Single-dose fed pharmacokinetics will be characterized in 48 healthy, adult volunteers, for a total of 48 healthy adult subjects. Approximately eight milliliter (1 × 8 mL) blood samples will be collected in K3 EDTA tubes at pre-dose and the following times after dosing: at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours. The collected blood samples will be transferred into centrifugation room at controlled temperature (2-8°C) and start centrifuged at 4±2°C within 2 hours after blood sample collection. Up to four (4) aliquots of plasma will be added in four pre-labeled cryovials for approximately 1 mL per each cryovial. Two aliquots for analyze vildagliptin and two aliquotes for analyze metformin. Cryovials containing plasma sample will be transferred to deep freezer in controlled temperature (2-8 °C) and will be stored at -70±10 °C. For the determination of the pharmacokinetic disposition of the formulations, there will be a total of 48 blood samples involving a total of 385 mL (including 10 mL for screening and 7 mL for post-study safety monitoring) of blood collected for pharmacokinetic analysis from each subject who provid their complete all blood collections in the study. There will be at least 7 days between dosing times for the treatment periods. The bioequivalence of Vildagliptin and Metformin tablets 50/1000 mg manufactured by Mylan Laboratories Limited, India to GALVUS MET (50mg/1000 mg) tablets manufactured by NOVARTIS PHARMA PRODUKTIONS GmbH, Germany will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of Vildagliptin and Metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
48
Vildagliptin and Metformin tablets 50/1000 mg manufactured by Mylan Laboratories Limited, India
Vildagliptin and Metformin tablets 50/1000 mg manufactured by NOVARTIS PHARMA PRODUKTIONS GmbH, Germany.
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t)
pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post-dose.
Time frame: Blood samples will be collected for PK analyses in each period pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post-dose.
Maximal measured plasma concentration (Cmax)
pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post-dose.
Time frame: Blood samples will be collected for PK analyses in each period pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00 and 36.00 hours post-dose.
Number of subjects with adverse events
An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Approximately the day 14 after the last visit
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