Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets

NCT06248801 | Unknown Phase 1

• 1 other identifier: VME-005-22
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy Subjects

Keywords

Bioequivalence Vildagliptin and Metformin tablets 50/1000 mg

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

Secondary Outcomes (1)

• Number of subjects with adverse events

  Approximately the day 14 after the last visit

Study Arms (2)

Sequence 1-Vildagliptin and Metformin test product and then reference product

EXPERIMENTAL

Participants will receive treatment 1 in period 1 and treatment 2 in period 2. Where treatment 1= Vildagliptin and Metformin tablets 50/1000 mg test product, treatment 2= Vildagliptin and Metformin tablets 50/1000 mg reference product.

Drug: Vildagliptin and Metformin-Test product

Sequence 1-Vildagliptin and Metformin reference product and then test product

EXPERIMENTAL

Participants will receive treatment 2 in period 1 and treatment 1 in period 2. Where treatment 1= Vildagliptin and Metformin tablets 50/1000 mg test product, treatment 2= Vildagliptin and Metformin tablets 50/1000 mg reference product.

Drug: Vildagliptin and Metformin-Reference product

Interventions

Vildagliptin and Metformin-Test product DRUG

Vildagliptin and Metformin tablets 50/1000 mg manufactured by Mylan Laboratories Limited, India

Sequence 1-Vildagliptin and Metformin test product and then reference product

Vildagliptin and Metformin-Reference product DRUG

Vildagliptin and Metformin tablets 50/1000 mg manufactured by NOVARTIS PHARMA PRODUKTIONS GmbH, Germany.

Sequence 1-Vildagliptin and Metformin reference product and then test product

Eligibility Criteria

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

You may qualify if:

• Age: 18 - 55 years, Subject must meet age requirements at the time of signing the initial informed consent and the initial study medication administration.
• Sex: Males and/or non-pregnant, non-lactating females.
• Women of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) pregnancy test performed on screening day and prior to the initial dose of each period of study medication.
• Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
• postmenopausal with spontaneous amenorrhea for at least one (1) year
• bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
• total hysterectomy and an absence of bleeding for at least 3 months.
• Weight: Each subject is required to have a Body Mass Index (BMI) value less than or equal to 30.0 kg/m2 but greater than or equal to 18.5 kg/m2. All weight values are to be reported according to the scale's precision. The subject's height is to be reported in centimeters to the nearest tenth. Each subject's BMI is to be calculated using the reported weight in kilograms and height in centimeters and it is to be reported to the nearest tenth (26.3 kg/m2).
• Smoking Status: Moderate smokers (up to 10 cigarettes or equivalent per day refer to Appendix VII: Nicotine Equivalence Estimates) are permitted.
• Documentation of smoking status is to be via the questionnaire in Appendix VI, with results included in the study database (if applicable), and Subject's CRF.
• Adequate venous access in both arms for the collection of a number of blood samples during the study.
• Able to understand and sign the written Informed Consent Form.
• a. Utilization of illiterate subjects is permitted when performed according to GCP, as well as regulations/guidances for the region of submission and country of conductance.
• Willing to follow the protocol requirements and comply with protocol restrictions and allow investigators to draw approximately 7 mL of blood for monitoring subjects' safety after the completion of the study.
• Willing to follow precautions during driving and operating machines

You may not qualify if:

• Serum Chemistries Alkaline Phosphatase Albumin Creatinine AST Blood sugar (by DTX) Total Protein Total Bilirubin ALT Direct Bilirubin BUN
• Hematology Platelet Count White Blood Cell Count Hemoglobin Hematocrit Red Blood Cell Count Neutrophils Lymphocytes Monocytes Eosinophils Basophils MCV, MCH, MCHC
• Additional tests may be performed, if necessary, based on standard lab panels utilized by the clinical site.
• Normal or non-clinically significant 12-lead EKG
• Negative Hepatitis B antigen test
• Negative Hepatitis C antibody test
• Negative HIV test
• Negative urine drug screen including at a minimum Metamphetamines, benzodiazepines, cocaine, opioids and Marijuana (THC),
• if tobacco/nicotine use is suspected, a urine cotinine test may be performed at the discretion of the Principal Investigator or responsible physician and if performed, must be negative,
• if warranted, other tests and/or examinations may be performed at the discretion of the Principal Investigator or responsible physician.
• Institutionalized subjects.
• Social Habits:
• Consumption of any alcoholic beverage within the 48 hours prior to the initial administration of study medication and until the completion of each period of the study.
• Consumption of any caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial administration of study medication and until the completion of each period of the study.
• Consumption of seville oranges grapefruit, grapefruit-like, or grapefruit containing products within 48 hours prior to the initial administration of the study medication and until the completion of each period of the study.

Sponsors & Collaborators

• Bio-innova Co., Ltd: lead

MeSH Terms

Interventions

Vildagliptin

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Sasitorn Kittivoravitkul, Ph.D.

CONTACT

022549008; sasitorn_k@bio-innova.com

Somkiat Tatritorn, M.D.

CONTACT

022549008; somkiat_t@bio-innova.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: September 5, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 15, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share