An open label, randomized, balanced, two treatment, two sequence, two period, cross-over, single-dose, oral bioequivalence study of Dapagliflozin tablets 10 mg, Gliclazide Sustained Release Tablets 60 mg and Metformin Hydrochloride Sustained Release Tablets 500mg (T) Manufactured by Eris Lifesciences Ltd., India with Xigduo® XR 10 mg/ 500 mg (Dapagliflozin 10 mg and Metformin Hydrochloride Extended Release Tablets 500 mg) (R1) Manufactured by AstraZeneca Pharmaceuticals LP, USA and Imported & Marketed by AstraZeneca Pharma India Ltd., Bangalore, India and Diamicron® XR 60 mg (Gliclazide Extended Release Tablet 60 mg) (R2) Manufactured by Serdia Pharmaceuticals (India) Pvt, Ltd., India in normal healthy, adult human male subjects under fasting condition.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 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
After overnight fasting of at least 10.00 hours, a single dose of Dapagliflozin tablets 10 mg, Gliclazide Sustained Release Tablets 60 mg and Metformin Hydrochloride Sustained Release Tablets 500mg (T) Manufactured by Eris Lifesciences Ltd., India or Xigduo® XR 10 mg/500 mg (Dapagliflozin 10 mg and Metformin Hydrochloride Extended-Release Tablets 500 mg) (R1) Manufactured by AstraZeneca Pharmaceuticals LP, USA and Imported & Marketed by AstraZeneca Pharma India Ltd., Bangalore, India and Diamicron® XR 60 mg (Gliclazide Extended Release Tablet 60 mg) (R2) Manufactured by Serdia Pharmaceuticals (India) Pvt, Ltd., India along with 240±2 mL of 20% aqueous glucose solution, will be administered orally to the subjects in sitting posture at ambient temperature in the morning, as per the randomization schedule.
Subjects will receive the alternate ‘treatment’ in the subsequent periods, in such a way that each subject will have received all the ‘treatments’ by the end of the study.
Note: Investigational products should be administered with 240±2 mL of a 20% aqueous glucose solution, followed by 60 mL of the 20% aqueous glucose solution administered every 15 minutes (window period of ± 5 minutes) for upto 04 hours after dosing.
研究设计
- 研究类型
- Ba/be
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Volunteers who accept for participating in this study must:
- •Healthy, adult human, male 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 29.99 kg/m2 (both inclusive) at the time of screening.
- •Normal or clinically insignificant findings during screening, medical history, and clinical examination including vital signs, 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.
- •Compliance with study-specific restrictions and prohibitions.
- •Able to give voluntary written informed consent for participation in the trial.
排除标准
- •If any subject is having any of the following conditions, then exclude him from participation in this study:
- •Known hypersensitivity or idiosyncratic reaction to the study drug or any related drug.
- •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.
- •Ingestion of any medicine at any time within 14 days prior to IP administration in period I.
- •In any such case, subject selection will be at the discretion of the principal investigator.
- •Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
- •Smokers and Alcoholics.
- •History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study check-in.
- •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.
- •The presence of clinically significant abnormal laboratory values during screening.
- •Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and Urine alcohol test.
- •A history of difficulty with donating blood or having donated blood in the preceding 90 days for males prior to the start of the study
- •Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days for males preceding the start of the study.
- •Difficulty in swallowing capsule/tablet.
- •Positive HIV, VDRL/RPR, Hepatitis B and C tests.
- •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.
结局指标
主要结局
Cmax, AUC(0-t) and AUC(0-inf)
时间窗: Total 28 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 5.0 ml will be collected and placed in Ice cold bath at each period. | The post-dose blood samples of 5.0 mL will be collected and placed in Ice cold bath at 00.33, 00.67, 01.00, 01.33, 01.67, 02.00, 02.33, 02.67, 03.00, 03.50, 04.00, 04.50, 05.00, 05.50, 06.00, 06.50, 07.00, 07.50, 08.00, 09.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose.
次要结局
- Tmax, Kel, t½ and AUCExtrapolated%(Total 28 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 5.0 mL will be collected and placed in Ice cold bath at each period.)
研究者
Dr Divya A
Notrox Research Pvt Ltd