None listed
Conditions
Interventions
Intervention1: Test Product: Gliclazide 60 mg and metformin
hydrochloride 1000 mg extended
release tablets
one single tablet
oral dose
Control Intervention1: Reference product: Reclimet XR Forte Tab
Sponsors
Serdia Pharmaceuticals India pvt ltd
Eligibility
Inclusion criteria
Inclusion criteria: Willing to be available for the entire study period and to comply protocol requirements; Healthy, adult, human subject of 18-45 years (both inclusive) of age; Body mass index in the range of 18.50 – 30.00 kg/m2 (both inclusive); Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs measurements and clinical examination at the time of screening as well as check-in of each study period; Normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis; Normal or clinically non-significant 12-lead ECG recording Non-smokers or mild/moderate smokers with not more than 10 bidis/cigarettes/pipes per day, and willing to abstain from smoking or chewing any tobacco containing products at least 72.00 hours prior to check-in until last sample collection in each study period; Willing to abstain from alcohol or alcoholic products at least 24.00 hours prior to check-in until last sample collection in each study period; Willing to abstain from xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks), at least 48.00 hours prior to check-in until last sample collection in each study period; Willing to abstain from grapefruit or its juice at least 72.00 hours prior to check-in until last sample collection in each study period;
Exclusion criteria
Exclusion criteria: Use of any prescribed medication (including herbal medicines and vitamin supplements) or OTC products within 30 days prior to first check-in and throughout the study; History or presence of significant gastric and/or duodenal ulceration; Difficulty in swallowing tablets or capsules; Use of any recreational drug or history of drug addiction; Participated in any clinical investigation requiring repeated blood sampling or have donated blood in past 90 days prior to first check-in; Positive urine alcohol or urine drug of abuse tests during check-in of each study period; Positive test for Human Immunodeficiency Virus (HIV) type I/II antibodies, Hepatitis B surface antigen (HBsAg) and Hepatitis C virus antibodies; History of allergy or hypersensitivity intolerance to Gliclazide and Metformin or its formulation excipients which, in the opinion of a clinical investigator, would compromise the safety of the subject or the study; History of difficulty in accessibility of veins in arms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess bioequivalence of the test product in comparison with the reference product Timepoint: Blood samples will be drawn at 0.00 (within 2.00 hours prior to dosing), 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 16.00, 20.00, 24.00, 36.00, 48.00, 72.00 and 96.00 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess safety and tolerability of the test product in comparison with the reference product. Timepoint: -24.00 (±45 minutes of scheduled time), 0.00 (within 2.00 hours) hours prior to dosing and at 3.00, 6.00 and 11.00 hours post-dose (±45 minutes of scheduled time) | — |
Countries
India
Contacts
Public ContactSofi Joseph
Serdia Pharmaceuticals (India) Pvt. ltd
Outcome results
None listed