CTRI/2022/11/047234已完成2 期
An open-label, randomized, balanced, two-treatment, two-sequence, two-period, cross-over, single-dose, oral bioequivalence study of Dapagliflozin 10mg and Vildagliptin Sustained Release tablets 100 mg (T) Manufactured by Eris Lifesciences Ltd, India with Zomelis-D (Dapagliflozin 10mg and Vildagliptin Sustained Release tablets 100 mg) (R) Manufactured by Exemed Pharmaceuticals., India in normal healthy, adult human subjects under fasting condition
Eris Lifesciences Ltd.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年11月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax, AUC(0-t) and AUC(0-inf)
研究概览
简要总结
An open label, randomized, balanced, two treatment, two sequence, two period, cross-over,single-dose, oral bioequivalence study of Dapagliflozin 10mg and Vildagliptin Sustained Release tablets 100 mg (T) Manufactured by Eris Lifesciences Ltd, India with Zomelis®-D (Dapagliflozin 10mg and Vildagliptin Sustained Release tablets 100 mg) (R) Manufactured by Exemed Pharmaceuticals., India in normal healthy, adult human subjects under fasting condition.
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Volunteers who accept for participating in this study must:
- •Healthy, adult human, subjects aged between 18-45 years (both inclusive) weighing at least 50 kg at the time of screening.
- •Having a Body Mass Index (BMI) between 18.50 to 30.00 kg/m2 (both inclusive) at the time of screening.
- •Normal or clinically insignificant findings during screening, medical history, medical examination, laboratory evaluations, 12 lead ECG and X-ray chest (posterior-anterior view) recordings.
- •Able to comply with the study procedures, in the opinion of the principal investigator.
- •Able to give voluntary written informed consent for participation in the trial.
- •Preferably non smoker and non alcoholic.
- •In case of Female subjects: Female subjects who are of child bearing potential and are surgically sterilized at least 6 months prior to study participation.
- •Female subjects who are of childbearing potential and are willing to use a suitable and effective double barrier contraceptive method or non-hormonal intra uterine device during the study.
- •Female subjects who are tested negative for serum pregnancy test at the time of check-in.
- •Female subjects who are tested negative for urine pregnancy test at the time of screening.
- •Female subjects who has surgically sterilized partner (for at least 6 months).
排除标准
- •If any subject is having any of the following conditions, then exclude him/her from participation in this study: 1.Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
- •2.History or presence of any disease or disorder known to influence bone metabolism, compromise the hemopoietin, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, musculoskeletal or any other body system.
- •3.Systolic blood pressure less than 90 mmHg or more than 140 mmHg at the time of screening.
- •5.Pulse rate below 60 beats/minute or above 100 beats/minute at the time of screening.
- •7.Body temperature below 96.2o F or above 99.8 o F at the time of screening.
- •8.SpO2 less than 94% @ RA at the time of screening.
- •9.Ingestion of any medicine at any time within 14 days prior to IP administration 10.in period I.
- •In any such case subject selection will be at the discretion of the principal investigator.
- •11.Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
- •12.Smokers who smoke >9 cigarettes per day.
- •13.Alcoholic who consumes >21units of alcohol in a week.
- •14.History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
- •15.An unusual or abnormal diet within 48.00 hours prior to study check-in, whatever reason e.g. because of fasting due to religious reasons.
- •16.The presence of clinically significant abnormal laboratory values during screening.
- •17.Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and Urine alcohol test.
- •18.A history of difficulty with donating blood or having donated blood in the preceding 90 days prior to the start of the study.
- •19.Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days preceding the start of the study.
- •22.Subjects who have used any drugs or substances known to be strong inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I.
- •23.History of undiagnosed vaginal bleeding (for females only).
- •24.Female subjects who demonstrates a positive pregnancy during screening or currently breast-feeding.
- •25.Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
结局指标
主要结局
Cmax, AUC(0-t) and AUC(0-inf)
时间窗: Total 24 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 4.0 mL will be collected in each period. | The post-dose blood samples of 4.0 mL will be collected at 00.25, 00.50, 00.75, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 09.00, 10.00, 12.00, 16.00, 20.00, 24.00, 36.00 and | 48.00 hours post-dose. | 36.00 and 48.00 hours ambulatory visit. (window period as ± 60 minutes)
次要结局
- Tmax, Kel, t½ and AUC% Extrap obs(%)(Total 24 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 4.0 mL will be collected in each period.)
研究者
研究点 (1)
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