Healthy Subjects Clinical Trial
Official title:
A Bioequivalence Study of Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets in Healthy Thai Adult Volunteers Under Fed Condition.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05483998 -
A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants
|
Phase 1 | |
| Recruiting |
NCT02235012 -
Cognitive Biases Under Ketamine
|
N/A | |
| Recruiting |
NCT02417714 -
Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
|
||
| Completed |
NCT04418973 -
Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.
|
N/A | |
| Completed |
NCT05088343 -
Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects
|
Phase 1 | |
| Terminated |
NCT04068259 -
Single Ascending Dose Study of PBI-4547 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03279302 -
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
|
Phase 1 | |
| Not yet recruiting |
NCT06233162 -
Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets
|
Phase 1 | |
| Recruiting |
NCT04159844 -
Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
|
N/A | |
| Completed |
NCT06137911 -
Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.
|
Phase 1 | |
| Completed |
NCT04849286 -
Measurement of HTL0016878 in Cerebrospinal Fluid
|
Phase 1 | |
| Not yet recruiting |
NCT06233227 -
Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule
|
Phase 1 | |
| Completed |
NCT04096157 -
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
|
Phase 1 | |
| Completed |
NCT01200368 -
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
|
Phase 3 | |
| Recruiting |
NCT05805033 -
Peri-Implant Soft Tissue Integration in Humans: Influence of Material
|
N/A | |
| Completed |
NCT04027803 -
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
|
Phase 1 | |
| Recruiting |
NCT03467880 -
Multicenter Study of Impulse Oscillometry in Chinese
|
N/A | |
| Completed |
NCT02903095 -
Single Ascending Dose Study of TD-1439 in Healthy Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT02341508 -
A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT02532998 -
A Study to Assess the Pharmacodynamic Effect of Single Doses of AZD9977 in Healthy Male Subjects
|
Phase 1 |