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.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To assess bioequivalence of the test product in comparison
研究概览
简要总结
Serdia Pharmaceuticals (India) Pvt. Ltd. has developed a fixed dose combination tablet containing gliclazide 60 mg with metformin 1000 mg ( both extended release) as a bi-layered tablet. Similar product is approved in India manufactured and marketed by Dr. Reddy’s Laboratories Ltd., India.
This proposed project is an open-label, balanced,randomized, two treatment, two sequence, two period, two way cross-over, singleoral dose bioequivalence study Gliclazide 60 mg and metformin hydrochloride1000 mg extended release tablets of Serdia Pharmaceuticals (India), Pvt. Ltd.,with Reclimet XR Forte Tablets (Gliclazide and metformin extended releasetablets 60mg+1000 mg) of DrReddy’s Laboratories Ltd, India in healthy, adult, male human subjectsunder fasting conditions.
研究设计
- 研究类型
- Ba/be
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •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;.
排除标准
- •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.
结局指标
主要结局
To assess bioequivalence of the test product in comparison
时间窗: 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
with the reference product
时间窗: 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
次要结局
- To assess safety and tolerability of the test product in(comparison with the reference product.)