An Open label, balanced, randomized, twotreatment, twoperiod, twosequence, single oral dose, crossover, bioequivalence study on Sitagliptin Phosphate 100 mg and Metformin Hydrochloride 1000 mg XR tablet of Laboratorios LETI S.A.V., Vs Janumet 100 and 1000 mg XR tablet Sitagliptin Phosphate 100 mg and Metformin Hydrochloride 1000 mg of Merck Sharp and Dohme Corp 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
- 24
- 试验地点
- 1
- 主要终点
- Cmax, AUC0-t and AUC0-∞
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 on Sitagliptin Phosphate 100 mg + Metformin Hydrochloride1000 mg XR tablet of Laboratorios LETI S.A.V., Vs Janumet 100/1000 mg XR tablet(Sitagliptin Phosphate 100 mg + Metformin Hydrochloride 1000 mg) of Merck Sharp& Dohme Corp in healthy adult human subjects under fasting conditions.
Test product (T):
Sitagliptin Phosphate 100 mg + MetforminHydrochloride 1000 mg XR tablet of Laboratorios LETI S.A.V
Reference product (R):
Janumet 100/1000 mg XR tablet(SitagliptinPhosphate 100 mg + Metformin Hydrochloride 1000 mg) of Merck Sharp & Dohme Corp
24 subjects will be enrolled in the study .
Primary objective:
To compare rateand extend of orally administered molecule to prove bioequivalence on SitagliptinPhosphate 100 mg + Metformin Hydrochloride 1000 mg XR tablet of Laboratorios LETIS.A.V., with Janumet 100/1000 mgXR tablet(SitagliptinPhosphate 100 mg + Metformin Hydrochloride 1000 mg) of Merck Sharp & Dohme Corpin healthy adult human subjects under fastingconditions.
Secondary objective:
To monitor the safety of the study subjectsafter administration of Sitagliptin Phosphate 100 mg + Metformin Hydrochloride 1000mg XR tabletsin healthy adult human subjects under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
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.Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of 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 (g/dL) for men and 12 to 16 g/dL for female.
- •6.Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period.
排除标准
- •1.Found Positive (+Ve) on Rapid antigen test for COVID-19 during screening.
- •2.Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women.
- •3.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and blood–forming organs.
- •4.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
- •5.History of severe infection or major surgery in the past 6 months.
- •6.History of Minor surgery or fracture within the past 3 months.
结局指标
主要结局
Cmax, AUC0-t and AUC0-∞
时间窗: From day 1 to day 12
次要结局
- Tmax , Extrap_obs, λz and t1/2(From day 1 to day 12)