AN OPEN LABEL, RANDOMIZED, TWO TREATMENT, TWO PERIOD, SINGLE DOSE & MULTIPLE DOSE, TWO-ARM, TWO WAY CROSSOVER, STEADY STATE STUDY TO ASSESS THE PHARMACOKINETIC PROFILE AND COMPARE THE DPP-4 INHIBITION ACTIVITY OF VILDAGLIPTIN MR 100MG TABLET QD [TEST PRODUCT (A)] OF NOVARTIS HEALTHCARE PVT LTD, INDIA WITH VILDAGLIPTIN 50 MG IR TABLETS BID [REFERENCE PRODUCT (B)] OF NOVARTIS HEALTHCARE PVT. LTD, INDIA IN HEALTHY ADULT, HUMAN SUBJECTS, UNDER FASTING CONDITIONS.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Novartis India Limited
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The Stage 1 will be of 30 subjects.
Study Overview
Brief Summary
| Name of Sponsor: |
Novartis Healthcare Pvt Ltd., India.
|Study Drug:
Test Product (A)
Reference product (B)
|Vildagliptin MR 100mg tablet of Novartis Healthcare Pvt Ltd, India.
Vildagliptin 50 mg IR tablets of Novartis Healthcare Pvt. Ltd, India.
|Title of Study:
An open label, randomized, two treatment, two period, single dose & multiple dose, two-arm, two way crossover, steady state study to assess the pharmacokinetic profile and compare the DPP-4 inhibition activity of vildagliptin MR 100mg tablet QD [Test Product (A)] of Novartis Healthcare Pvt Ltd, India with Vildagliptin 50 mg IR tablets BID [Reference Product (B)] of Novartis Healthcare Pvt. Ltd, India in healthy adult, human subjects, under fasting conditions.
| | |Clinical Study
Centre:
Ecron Acunova Limited (Formerly known as Manipal Acunova Limited), V floor, MCODS Building, KMC Hospital, Attavar, Mangalore- 575 001, India.
|Phase of
Development:
A Bioavailability study (Phase 1).
|Objectives:
**Primary objective:**The primary objective of this study is to compare the effect of Vildagliptin MR 100mg tablet QD with Vildagliptin 50 mg IR tablets BID on DPP-4 inhibition at steady state under fasting conditions.
Secondary objectives:
- • To evaluate the single dose and steady state pharmacokinetic profile of Vildagliptin MR 100mg tablet QD and Vildagliptin 50 mg IR tablets BID under fasting conditions.
- • To evaluate the safety profile of Vildagliptin MR 100mg tablet QD Vs Vildagliptin 50 mg IR tablets BID under fasting conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Body Mass Index of 18.50 to 29.90 Kg per meter square (both inclusive).
- •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.
- •Pre-study screening laboratory tests within normal or clinically non-significant limits as mentioned in lab values reference range in appendix four.
- •Negative test results for alcohol (in breath), negative urine drugs of abuse.
- •Who is negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR.
- •12 lead ECG recording either normal or clinically non-significant as per Investigator opinion.
- •Normal or clinically acceptable chest X-ray (PA) taken within 06 months before the day of dosing.
- •Who will be available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff.
- •Female volunteers having a negative result in urine pregnancy test during screening and at the time of check-in.
- •Male subjects and, or Female subject’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
- •Known allergic to Vildagliptin or any component of the formulation and to any other related drug.
- •History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease and malignancy.
- •Female volunteers who are breast feeding or are found positive in urine pregnancy test.
- •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.
- •History of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) or chronic consumption of tobacco products.
- •History of vascular collapse.
- •Who is scheduled for surgery any time during study or within 07 days after study completion.
- •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.
- •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.
- •Who was hospitalized within 28 days prior to administration of the study medication.
- •History of difficulty in swallowing.
- •Who has unsuitable veins for repeated venipuncture.
- •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.
- •Who has Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
- •Who has Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
Outcomes
Primary Outcomes
The Stage 1 will be of 30 subjects.
Time Frame: Day 1 to Day 6
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.
Time Frame: Day 1 to Day 6
This bioequivalence study is planned to conduct in two Stages in healthy human adult male and/or female subjects.
Time Frame: Day 1 to Day 6
Secondary Outcomes
- 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) – Type, nature, frequency and severity.)