CTRI/2022/11/047371 [Registered on: 16/11/2022] Trial Registered Prospectively
Last Modified On:
16/02/2023
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Bioequivalence study of Sitagliptin and Gliclazide Sustained Released Tablets under fasting condition.
Scientific Title of Study
An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single dose, oral bioequivalence study of Sitagliptin 100 mg and Gliclazide 60mg SR tablets (T) Manufactured by Eris Lifesciences Ltd, India with Januvia 100 mg (Sitagliptin Phosphate Tablets IP 100 mg) (R1) Manufactured by MSD Pharmaceuticals Pvt. Ltd. India and Diamicron XR 60mg (Gliclazide extended release tablet) (R2) Manufactured by Serdia Pharmaceuticals (India) Pvt, Ltd., India in normal healthy, adult human subjects under fasting condition.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
S-22-709 Version No. 01, Dated 22-08-2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr A Divya
Designation
PI
Affiliation
Notrox Research Pvt. Ltd.
Address
2nd Floor, Bikasipura road, JC Industrial layout, off Kanakapura Road
Bangalore KARNATAKA 560062 India
Phone
Fax
Email
drdivya-a@notroxresearch.com
Details of Contact Person Scientific Query
Name
Ganesh Boddu
Designation
Head- Regulatory Affairs and Clinical Research
Affiliation
Eris Lifesciences Ltd.
Address
Shivarth Ambit,
Ramdas Road Off SBR
Near Swati Bungalows
Ahmadabad GUJARAT 380054 India
Phone
Fax
Email
Ganesh.boddu@erislifesciences.com
Details of Contact Person Public Query
Name
Ganesh Boddu
Designation
Head- Regulatory Affairs and Clinical Research
Affiliation
Eris Lifesciences Ltd.
Address
Shivarth Ambit,
Ramdas Road Off SBR
Near Swati Bungalows
Bijapur GUJARAT 380054 India
Phone
Fax
Email
Ganesh.boddu@erislifesciences.com
Source of Monetary or Material Support
Eris Lifesciences Ltd.
Brahmaputra Industrial Park, Village-Silla, Amingaon, North Guwahato, Assam-781031
Primary Sponsor
Name
Eris Lifesciences Ltd.
Address
Shivarth Ambit,
Ramdas Road Off SBR
Near Swati Bungalows,
Bodakdev
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Divya A
Notrox Research Pvt. Ltd.
Notrox Research Pvt. Ltd.
No 19/3,2nd Floor, Bikasipura road, JC
Industrial layout, off Kanakapura Road (Behind
Metro Cash & carry) Bangalore,560062,
Karnataka India. Bangalore KARNATAKA
After an overnight fasting of at least 10.00 hours, a single dose SJanuvia 100 mg (Sitagliptin Phosphate Tablets IP 100 mg) (R1) Manufactured by MSD Pharmaceuticals Pvt.
Ltd. India and Diamicron XR 60mg (Gliclazide extended release tablet) (R2) Manufactured by Serdia Pharmaceuticals (India) Pvt, Ltd., India along with 240±2 mL of 20% aqueous glucose solution, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule. Subjects will receive the alternate ‘treatment’ in the subsequent periods, in such a way that each subject will have received all the ‘treatments’ by the end of the study.
Intervention
Sitagliptin 100 mg and Gliclazide 60mg SR tablets.
Manufactured by: Eris Lifesciences Ltd, India.
After an overnight fasting of at least 10.00 hours, a single dose Sitagliptin
100 mg + Gliclazide 60mg SR tablets (T) Manufactured by Eris
Lifesciences Ltd, India along with 240±2 mL of 20% aqueous glucose solution, will be
administered orally to the subjects in sitting posture at ambient
temperature in the morning, as per the randomization schedule.
Subjects will receive the alternate ‘treatment’ in the subsequent periods,
in such a way that each subject will have received all the ‘treatments’ by
the end of the study.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
Volunteers who accept for participating in this study must
1. Healthy, adult human, subjects aged between 18-45 years (both inclusive) weighing at least 50 kg at the time of screening.
2. Having a Body Mass Index (BMI) between 18.50 to 30.00 kg/m2 (both inclusive) at the time of screening.
In case of Female subjects
8. Female subjects who are of child bearing potential and are surgically sterilized at least 6 months prior to study participation.
9. Female subjects who are of child bearing potential and are willing to use a suitable and effective double barrier contraceptive method or non-hormonal intra uterine device during the study.
10. Female subjects who are tested negative for serum pregnancy test (for female) at the time of check in of each period.
11. Female subjects who are tested negative for urine pregnancy test (for female) at the time of screening.
12. Female subjects who has surgically sterilized partner (for at least 6 months).
3. Normal or clinically insignificant findings during screening, medical history, medical examination, laboratory evaluations, 12 lead ECG and X-ray chest (posterior-anterior view) recordings.
4. Able to comply with the study procedures, in the opinion of the principal investigator.
5. Compliance with study specific restrictions and prohibitions.
6. Able to give voluntary written informed consent for participation in the trial.
7. Preferably non smoker and non alcoholic.
ExclusionCriteria
Details
If any subject is having any of the following conditions, then exclude him/her from
participation in this study
1. Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
2. History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietin, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system.
3. Systolic blood pressure less than 90 mmHg or more than 140 mmHg at the time of screening. Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.
4. Diastolic blood pressure less than 60 mmHg or more than 90 mmHg at the time of screening. Minor deviations (2-4 mmHg) may be acceptable at the discretion of the physician/investigator.
5. Pulse rate below 60 beats/minute or above 100 beats/minute at the time of screening and check-in.
6. Respiratory rate below 12 or above 20 breaths per minute at the time of screening and check-in. • Body temperature below 96.2o F or above 99.8 o F at the time of screening.
7. Ingestion of any medicine at any time within 14 days prior to IP administration in period I. In any such case subject selection will be at the discretion of the principal investigator.
8. Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
9. Smokers who smoke >9 cigarettes per day.
10. Alcoholic who consumes >21units of alcohol in a week.
11. History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
12. An unusual or abnormal diet within 48.00 hours prior to study check-in, whatever reason e.g. because of fasting due to religious reasons.
13. The presence of clinically significant abnormal laboratory values during screening.
14. Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and Urine alcohol test.
15. A history of difficulty with donating blood or having donated blood in the preceding 90 days prior to the start of the study.
16. Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days preceding the start of the study.
17. Difficulty in swallowing capsule/tablet.
18. Positive HIV, VDRL/RPR, Hepatitis B and C tests.
19. Subjects who have used any drugs or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I.
20. History of undiagnosed vaginal bleeding (for females only).
21. Female subjects who demonstrates a positive pregnancy during screening or currently breast-feeding.
22. Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Cmax, AUC(0-t) and AUC(0-inf)
Total 29 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood
sample of 4.0 mL will be collected in each period.
The post-dose blood samples of 4.0 mL will be collected at 00.33, 00.67, 01.00, 01.33,
01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50,
07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 and 96.00
hours post-dose.
36.00, 48.00 72.00 and 96.00 hours ambulatory visit. (window period as ± 60
minutes).
Secondary Outcome
Outcome
TimePoints
Tmax, Kel, t½ and AUC% Extrap obs(%)
Total 29 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood
sample of 4.0 mL will be collected in each period.
The post-dose blood samples of 4.0 mL will be collected at 00.33, 00.67, 01.00, 01.33,
01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50,
07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 and 96.00
hours post-dose.
36.00, 48.00 72.00 and 96.00 hours ambulatory visit. (window period as ± 60
minutes).
Target Sample Size
Total Sample Size="24" Sample Size from India="24" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single dose, oral bioequivalence study of Sitagliptin 100 mg + Gliclazide 60mg SR tablets (T) Manufactured by Eris Lifesciences Ltd, India with Januvia® 100 mg (Sitagliptin Phosphate Tablets IP 100 mg) (R1) Manufactured by MSD Pharmaceuticals Pvt. Ltd. India and Diamicron® XR 60mg (Gliclazide extended release tablet) (R2) Manufactured by Serdia Pharmaceuticals (India) Pvt, Ltd., India in normal healthy, adult human subjects under fasting condition.