An open label, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study of Metformin Hydrochloride 1000 mg XR tablet of Laboratorios LETI S.A.V., in comparison with Glucophage 1000 mg XR tablet (Metformin Hydrochloride 1000 mg) of Merck Serono GmbH in healthy adult human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To compare the rate and extent of absorption of orally administered Metformin Hydrochloride 1000 mg XR tablet of Laboratorios LETI S.A.V., with that of Glucophage 1000 mg XR tablet (Metformin Hydrochloride 1000 mg) of Merck Serono GmbH in healthy adult human subjects under fasting conditions.
研究概览
简要总结
An open label, balanced, randomized,two-treatment, two-period, two-sequence, single oral dose, crossover,bioequivalence study of Metformin Hydrochloride 1000 XR tablet mg of LaboratoriosLETI S.A.V., in comparison with Glucophage 1000 mg XR tablet(MetforminHydrochloride 1000 mg) of Merck Serono GmbH in healthy adult human subjects under fastingconditions.
Primary objective:
To compare therate and extent of absorption of orally administered Metformin Hydrochloride 1000mg XR tabletof LaboratoriosLETI S.A.V., with that of Glucophage 1000 mg XR tablet(MetforminHydrochloride 1000 mg) of Merck Serono GmbH in healthy adult human subjectsunder fasting conditions.
Secondary objective:
To monitor the safety and tolerability of thestudy subjects after administration of Metformin Hydrochloride 1000 mg XR tablet inhealthy adult human subjects under fasting conditions.
26 Normal healthy subjects will be enrolling in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study 2.Willing to be available for the entire study period and to comply with protocol requirements.
- •3.Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age.
- •4.Body mass index in the range of 18 – 30 kg/m2 (both inclusive).
- •5.Normal haemoglobin between 12.5 to 17.5 grams per deciliter (gm/dl) for men and 12 to 16 gm/dl for female or as per the discretion of PI/CI/Physician.
- •6.Normal health status as determined by medical history and physical examination by the PI/CI/Physician at the time of screening and vital signs (blood pressure) 7 With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis (included in section no.
- •8 With a normal or clinically non-significant 12-lead ECG.
- •9 With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies, Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV) antibodies.
排除标准
- •1.Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or blood–forming organs. 2.History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 3.History of severe infection or major surgery in the past 6 months. 4.History of Minor surgery or fracture within the past 3 months. 5.Significant history or current evidence of malignancy or chronic.
- •infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction. 6.Any major illness or hospitalization within 90 days prior to check-in of first period. 7.Any other clinical condition like diarrhea or vomiting within three days prior to check-in of any period. 8.Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during four weeks before check-in of the first period and throughout the duration of the study until the post study safety sample is collected. 9.Use of any depot injection or an implant of any drug within three months prior to check-in of the first period and throughout the duration of the study until the post study safety sample is collected.
结局指标
主要结局
To compare the rate and extent of absorption of orally administered Metformin Hydrochloride 1000 mg XR tablet of Laboratorios LETI S.A.V., with that of Glucophage 1000 mg XR tablet (Metformin Hydrochloride 1000 mg) of Merck Serono GmbH in healthy adult human subjects under fasting conditions.
时间窗: Day 1 to day 11
-Cmax, and AUC0-t and
时间窗: Day 1 to day 11
次要结局
- To monitor the safety and tolerability of the study subjects after administration of Metformin Hydrochloride 1000 mg XR tablet in healthy adult human subjects under fasting conditions.(Tmax, λz and t1/2)