An open label, randomized, balanced, two treatment, two sequence, two period, two way cross-over, single-dose, oral bioequivalence study of FDC of Vildagliptin Sustained Release 100mg, Dapagliflozin 10mg and Metformin Hydrochloride Sustained Release 1000mg Tablets (T) Manufactured By Eris Lifesciences Ltd., India with Zomelis®-DM Forte (Vildagliptin(As Sustained Release), Dapagliflozin and Metformin Hydrochloride (As Sustained Release) Tablets (100mg + 10mg + 1000mg) (R) Manufactured by Exemed Pharmaceuticals, Gujarat, India in normal healthy, adult human 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
- 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
After an overnight fasting of at least 10.00 hours, a single dose of FDC of Vildagliptin Sustained Release 100 mg, Dapagliflozin 10 mg and Metformin Hydrochloride Sustained Release 1000 mg Tablets (T) Manufactured by Eris Lifesciences Ltd., India or Zomelis® - DM Forte (Vildagliptin (As Sustained Release), Dapagliflozin and Metformin Hydrochloride (As Sustained Release) Tablets (100 mg + 10 mg + 1000 mg) (R) Manufactured by Exemed Pharmaceuticals, Gujarat, 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
- Interventional
- 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
- All
入选标准
- •Volunteers who accept for participating in this study must: (1) Healthy, adult human, subjects aged between 18-45 years (both inclusive) at the time of screening.
- •(2) Having a Body Mass Index (BMI) between 18.50 to 29.99 kg/m2 (both inclusive) at the time of screening.
- •(3) Normal or clinically insignificant findings during screening, medical history, clinical examination including vital signs, laboratory evaluations, 12 lead ECG, and X-ray chest (posterior-anterior view) recordings.
- •(4) Able to comply with the study procedures, in the opinion of the principal investigator.
- •(5) Compliance with study-specific restrictions and prohibitions.
- •(6) Able to give voluntary written informed consent for participation in the trial.
- •In the case of Female subjects: (1) Female subjects who are of child bearing potential and are willing to use a suitable and effective double barrier contraceptive method or non-hormonal intra-uterine device during the study.
- •(2) Female subjects who are tested negative for serum pregnancy test at the time of check-in.
- •(3) Female subjects who are tested negative for urine pregnancy test at the time of screening.
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) 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.
- •(4) Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
- •(5) Smokers and Alcoholics.
- •(6) History of dehydration from diarrhea, vomiting, or any other reason within a period of 24.00 hours prior to study check-in.
- •(7) 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.
- •(8) The presence of clinically significant abnormal laboratory values during screening.
- •(9) Use of any recreational drugs or history of drug addiction or testing positive in pre-study urine drug screening and Urine alcohol test.
- •(10) A history of difficulty with donating blood or having donated blood in the preceding 90 days for males / 120 days for females prior to the start of the study.
- •(11) Subject who has participated in any other clinical study involving drug administration and collection of blood samples in the 90 days for males / 120 days for females preceding the start of the study.
- •(12) Difficulty in swallowing capsule/tablet.
- •(13) Positive HIV, VDRL/RPR, Hepatitis B and C tests.
- •(14) 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.
- •(15) Pregnant and lactating women or those using hormonal contraceptives (oral/implants).
- •(16) History of undiagnosed vaginal bleeding (for females only).
- •(17) Female subjects who demonstrate a positive pregnancy during screening or currently breast-feeding.
- •(18) 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 23 blood samples in each period, a single pre-dose (-02.00 to 00.00) blood sample of 5.0 mL will be collected in Ice cold bath at each | period. The pre-dose and post-dose blood samples will be collected in pre-labeled K2EDTA vacutainers. | The post-dose blood samples of 5.0 mL will be collected in Ice cold bath at 00.33, 00.67, 01.00, 01.50, 02.00, 02.50, 03.00, 03.50, 04.00, | 04.50, 05.00, 05.50, 06.00, 07.00, 08.00, 12.00, 16.00, 20.00, 24.00, 30.00, 36.00, 48.00 hours post-dose
次要结局
- Tmax, Kel, t½ and AUCExtrapolated%
研究者
Dr Harisha C
Notrox Research Pvt Ltd