An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single oral dose bioequivalence study Gliclazide 60 mg and metformin hydrochloride 1000 mg extended release tablets of Serdia Pharmaceuticals (India), Pvt. Ltd., with Reclimet XR Forte Tablets (Gliclazide and metformin extended release tablets 60mg plus1000 mg) of Dr Reddy’s Laboratories Ltd, India in healthy, adult, male human subjects under fasting conditions.

Serdia Pharmaceuticals India pvt ltd0 个研究点目标入组 49 人开始时间: 待定最近更新: 2023年8月21日

试验速览

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•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;

•Use of any prescribed medication (including herbal medicines and vitamin
•supplements) or OTC products within 30 days prior to first check-in and throughout
•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
•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.

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