None listed
Conditions
Interventions
Intervention1: Vildagliptin: VILDAGLIPTIN MR 100MG TABLET QD [TEST PRODUCT (A)]
Control Intervention1: VILDAGLIPTIN: VILDAGLIPTIN 50 MG IR TABLETS BID [REFERENCE PRODUCT (B)]
Sponsors
Novartis India Limited
Novartis India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Body Mass Index of 18.50 to 29.90 Kg per meter square (both inclusive). 2. No evidence of underlying disease during the pre-study screening, medical history, physical examination and laboratory investigations performed within 21 days prior to commencement of the study. 3. Pre-study screening laboratory tests within normal or clinically non-significant limits as mentioned in lab values reference range in appendix four. 4. Negative test results for alcohol (in breath), negative urine drugs of abuse. 5. Who is negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR. 6. 12 lead ECG recording either normal or clinically non-significant as per Investigator opinion. 7. Normal or clinically acceptable chest X-ray (PA) taken within 06 months before the day of dosing. 8. Who will be available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff. 9. Female volunteers having a negative result in urine pregnancy test during screening and at the time of check-in. 10. Females with child-bearing potential must agree to use an acceptable method of contraception at least 2 days prior to dosing of IP, during the study & for 07 days following their last dose of IP. A standardized reliable method with Pearl index equal to 1 or lower should be used. 12. Male subjects and, or Female subjectâ??s partner must agree to use condoms, vasectomy or spermicide in addition to female contraception for additional protection against conception throughout the study and 07 days after last dose of IP.
Exclusion criteria
Exclusion criteria: 1. Known allergic to Vildagliptin or any component of the formulation and to any other related drug. 2. History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease and malignancy. 3. Female volunteers who are breast feeding or are found positive in urine pregnancy test. 4. History or presence of significant alcohol dependence (abuse) or drug abuse within the past 1 year, current alcohol abuse (more than 5 units per week, 1 unit equal to 10 mL or 8 g of pure alcohol) or suspected abuse. 5. History of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) or chronic consumption of tobacco products. 6. History/presence of Asthma, urticaria or other allergic type reactions after taking any medication. 7. History of vascular collapse. 8. Who is scheduled for surgery any time during study or within 07 days after study completion. 9. Who is participating in any other clinical or bioequivalence study or otherwise would have donated in excess of 350 mL of blood in the last 90 days. 10. Who has taken prescription medication or OTC products (including vitamins and natural products) within 14 days prior to dosing of IP in Period 1, including topical medication. 11. Who was hospitalized within 28 days prior to administration of the study medication. 12. History of difficulty in swallowing. 13. Who has unsuitable veins for repeated venipuncture. 14. Any abnormal laboratory value or physical finding which may interfere with the interpretation of test results or cause a health hazard for the volunteer if he participates in the study. 15. Who has Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg. 16. Who has Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This bioequivalence study is planned to conduct in two Stages in healthy human adult male and/or female subjects. The Stage 1 will be of 30 subjects. The Stage 2 will be conducted, if required. The sample size of this Stage will be decided on the basis of power obtained after the statistical analysis of data from Stage 1. Timepoint: Day 1 to Day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Descriptive statistics of Pharmacokinetic Parameters for Vildagliptin from Day 1 and day 06 will be drawn for Test Product (A) and Reference Product (B). Adverse Events (AEs) and Serious Adverse Events (SAEs) â?? Type, nature, frequency and severity.Timepoint: Day 1 to Day 6 | — |
Countries
India
Contacts
Public ContactDr Anup Thorat
Novartis Healthcare Pvt. Ltd
Outcome results
None listed