An open label, randomized, balanced, two treatment, two sequence, two-period, cross-over, single-dose, oral bioequivalence study of Sitagliptin tablets 100 mg, Gliclazide Sustained Release Tablets 60 mg and Metformin Hydrochloride Sustained Release Tablets 500 mg (T) Manufactured by Eris Lifesciences Ltd., India with ALSITA® -M 100 (Sitagliptin 100 mg and Metformin Hydrochloride Extended Release Tablets 500 mg) (R1) Manufactured by Alkem Health Science., India and Diamicron® XR 60 mg (Gliclazide Extended Release Tablet 60 mg) (R2) Manufactured by Serdia Pharmaceuticals (India) Pvt, Ltd., India in normal healthy, adult human male subjects under fasting condition.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Cmax, AUC(0-t) and AUC(0-inf)
Study Overview
Brief Summary
After an overnight fasting of at least 10.00 hours, a single dose of Sitagliptin tablets 100 mg, Gliclazide Sustained Release Tablets 60 mg and Metformin Hydrochloride Sustained Release Tablets 500 mg (T) Manufactured by Eris Lifesciences Ltd., India or ALSITA® -M 100 (Sitagliptin 100 mg and Metformin Hydrochloride Extended Release Tablets 500 mg) (R1) Manufactured by Alkem Health Science., India and Diamicron® XR 60 mg (Gliclazide Extended Release Tablet 60 mg) (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.
Note: Investigational products should be administered with 240±2 mL of a 20% aqueous glucose solution, followed by 60 mL of the 20% aqueous glucose solution administered every 15 minutes (window period of ± 5 minutes) for upto 04 hours after dosing.
Study Design
- Study Type
- Ba/be
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Volunteers who accept for participating in this study must: 1) Healthy, adult human, male subjects aged between 18-45 years (both inclusive) weighing at least 50 kg at the time of screening.
- •Having a Body Mass Index (BMI) between 18.50 to 29.99 kg/m2 (both inclusive) at the time of screening.
- •Normal or clinically insignificant findings during screening, medical history, and clinical examination including vital signs, laboratory evaluations, 12 lead ECG, and X-ray chest (posterior-anterior view) recordings.
- •Able to comply with the study procedures, in the opinion of the principal investigator.
- •Compliance with study-specific restrictions and prohibitions.
- •Able to give voluntary written informed consent for participation in the trial.
Exclusion Criteria
- •If any subject is having any of the following conditions, then exclude him from participation in this study: 1) Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
- •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.
- •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.
- •Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
- •Smokers and Alcoholics.
- •History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
- •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.
- •The presence of clinically significant abnormal laboratory values during screening.
- •Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and Urine alcohol test.
- •A history of difficulty with donating blood or having donated blood in the preceding 90 days for males prior to the start of the study.
- •Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days for males preceding the start of the study.
- •Difficulty in swallowing capsule/tablet.
- •Positive HIV, VDRL/RPR, Hepatitis B and C tests.
- •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.
Outcomes
Primary Outcomes
Cmax, AUC(0-t) and AUC(0-inf)
Time Frame: Total 28 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 5.0 mL will be collected and placed in Ice cold bath at each period. | The post-dose blood samples of 5.0 mL will be collected and placed in Ice cold bath 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 and 72.00 hours post-dose.
Secondary Outcomes
- Tmax, Kel, t½ and AUCExtrapolated%(Total 28 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 5.0 mL will be collected and placed in Ice cold bath at each period.)
Investigators
Dr Divya A
Notrox Research Pvt Ltd