| CTRI Number |
CTRI/2020/08/027200 [Registered on: 18/08/2020] Trial Registered Prospectively |
| Last Modified On: |
14/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
To compare Dipeptidyl peptidase- 4 enzyme inhibition activity of Vildagliptin MR 100mg vs Vildagliptin IR 50 mg & evaluate pharmacokinetic profile under fasting condition. |
|
Scientific 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. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CLAF237BIN01/102-19 Version 02 Dated 05 May 2020 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjula Shetty |
| Designation |
Principal Investigator |
| Affiliation |
Navitas Life Science |
| Address |
Ecron Acunova Limited (Formerly known as Manipal Acunova Limited),V floor, MCODS Building, KMC Hospital, Attavar, Mangalore - 575 001, India
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
918246621105 |
| Fax |
|
| Email |
manjula.shetty@navitaslifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup Thorat |
| Designation |
Franchise Medical Head |
| Affiliation |
Novartis Healthcare Pvt. Ltd |
| Address |
Novartis Healthcare Pvt. Ltd. The Inspire – BKC, 7th Floor, G-Block,
BKC Main Road, Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250243426 |
| Fax |
|
| Email |
anup_vilas.thorat@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anup Thorat |
| Designation |
Franchise Medical Head |
| Affiliation |
Novartis Healthcare Pvt. Ltd |
| Address |
Novartis Healthcare Pvt. Ltd. The Inspire – BKC, 7th Floor, G-Block,
BKC Main Road, Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912250243426 |
| Fax |
|
| Email |
anup_vilas.thorat@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Healthcare Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Novartis India Limited |
| Address |
Novartis Healthcare Pvt. Ltd. The Inspire – BKC, 7th Floor, G-Block,
BKC Main Road, Bandra Kurla Complex, Bandra East, Mumbai,
Maharastra- 400051 India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Novartis India Limited |
Novartis Healthcare Pvt. Ltd. The Inspire – BKC,
7th Floor, G-Block, BKC Main Road, Bandra
Kurla Complex, Bandra East, Mumbai,
Maharastra- 400051 India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manjula Shetty |
Ecron Acunova Limited |
Ecron Acunova Limited
(Formerly known as Manipal Acunova Limited),V floor, MCODS Building, KMC Hospital, Attavar,
Mangalore - 575 001, India
Dakshina Kannada
KARNATAKA |
91-824-6621105
91-824-2445011
manjula.shetty@navitaslifesciences.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Under Fasting |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
VILDAGLIPTIN |
VILDAGLIPTIN 50 MG IR TABLETS BID [REFERENCE PRODUCT (B)] |
| Intervention |
Vildagliptin |
VILDAGLIPTIN MR 100MG TABLET QD [TEST PRODUCT (A)] |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
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 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. |
|
| ExclusionCriteria |
| Details |
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. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
|
Day 1 to Day 6
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
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. |
Day 1 to Day 6 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/08/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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. |
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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.
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