Bioequivalence study of Sitagliptin and Gliclazide Sustained Released Tablets under fasting condition.

Phase 2

Completed

• Registration Number: CTRI/2022/11/047371
• Lead Sponsor: Eris Lifesciences Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmax, AUC(0-t) and AUC(0-inf)Timepoint: Total 29 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood <br/ ><br>sample of 4.0 mL will be collected in each period. <br/ ><br>The post-dose blood samples of 4.0 mL will be collected at 00.33, 00.67, 01.00, 01.33, <br/ ><br>01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, <br/ ><br>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 <br/ ><br>hours post-dose. <br/ ><br>36.00, 48.00 72.00 and 96.00 hours ambulatory visit. (window period as ± 60 <br/ ><br>minutes).

Secondary Outcome Measures

Name	Time	Method
Tmax, Kel, t½ and AUC% Extrap obs(%)Timepoint: Total 29 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood <br/ ><br>sample of 4.0 mL will be collected in each period. <br/ ><br>The post-dose blood samples of 4.0 mL will be collected at 00.33, 00.67, 01.00, 01.33, <br/ ><br>01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, <br/ ><br>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 <br/ ><br>hours post-dose. <br/ ><br>36.00, 48.00 72.00 and 96.00 hours ambulatory visit. (window period as ± 60 <br/ ><br>minutes).