None listed
Conditions
Interventions
Intervention1: Test Product - Empagliflozin 25 mg+ Metformin 1000mg Extended-Release Tablet of The ACME Laboratories Ltd: After an overnight fast of at least 10.00 hours before scheduled time for dosi
Sponsors
Faromed Lifescineces LLP (Subsidiary of Omnicals Pharma Pvt Ltd)
ICBio Clinical Research Private limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 of age. 4) Body mass index in the range of 18.5 – 30.0 kg-m2. 5) Healthy volunteers who are clinically non-anemic will be included as per the discretion of PI-CI-Physician. 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-body temperature) measurements at the time screening as well as throughout the study. 7) With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis. 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 or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies. 10) Non-smokers and willing to abstain from smoking or chewing any tobacco containing product at least 72.00 hours prior to dosing if have history of smoking habit and throughout the sampling points. 11) Male volunteer willing to use appropriate contraceptive measures to ensure that his female partner will not get pregnant for at least 15 days before 1st dosing till 15 days post last-dose- entire study period. 12) In case of female subjects 1. Negative urine pregnancy test during screening and negative serum beta-hcg test at check-in of each study period. 2. Female subjects with childbearing potential or those within their first two years of onset of menopausal syndrome must either abstain from sexual intercourse or using acceptable methods of birth control for at least 15 days before 1st dosing till 15 days post last-dose- entire study period (Acceptable birth control methods include barrier methods such as diaphragm-condom with or without spermicide or who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) has been performed). 15) Able to read and understand the Informed Consent Document as a whole and communicate effectively if required.
Exclusion criteria
Exclusion criteria: 1) Incapable of understanding the informed consent information. 2) History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. 3) History or presence of severe renal dysfunction, including those receiving dialysis and hepatic dysfunction. 4) History of Diabetes mellitus type 1, diabetic ketoacidosis including history of diabetic coma and precoma, acute or chronic metabolic acidosis, and Severe hepatic dysfunction (lack of experience of administration in order to provide adequate glycaemic control, such patients should be treated with insulin) 5) History or presence of active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities 6) History or presence of pre-existing gallbladder disease. 7) History or presence of mortality and coronary heart disease morbidity 8) Use of antihypertensive drugs and pressor Agents (e.g dopamine, dobutamine), use of CYP2D6 (e.g paroxetine, fluoxetine, and quinidine), use of monoamine oxidase Inhibitors in the previous 30 days before first drug administration and till the completion of the study. 9) History or presence of asthma, urticaria or other allergic reactions. 10) History or presence of gastric and or duodenal ulceration. 11) History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion. 12) History or presence of cancer. 13) Difficulty with donating blood. 14) Difficulty in swallowing solids like tablets. 15) Use of any prescribed medication including antihypertensive drugs, any systemic medication or herbal remedies, insulin and secretagogues, probenecid, gemfibrozil, Inhibitors of OCT1 (such as verapamil), Inducers of OCT1 (such as rifampicin), Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) and Inhibitors of both OCT1, OCT2 (such as crizotinib, olaparib), NSAIDs, including selective cyclo-oxygenase (COX) inhibitors, ACE inhibitors, angiotensin receptor antagonists and diuretics, especially loop diuretics, glucocorticoids and beta 2 agonists during the two weeks before the start of the study or vitamins, herbal products and OTC medicinal products during two weeks prior to study initiation. 16) Subject chewed tobacco-consumed pan or pan masala, gutkha, masala (containing beetle nut and tobacco), xanthine-containing foods or beverages (coffee, tea, chocolate, and caffeine-containing sodas, colas, etc) for 48.00 hours prior to initiation of the study till the end of the study. 17) Subjects consumed grapefruit juice and poppy containing foods for 72.00 hours prior to initiation of the study till the end of the study. 18) Major illness during the 180 days before screening. 19) Participation in a drug research study within 90 days of screening. 20) Donation of blood within 90 days of screening. 21) Positive screening test result for any one or more of the following HIV, Hepatitis B, Hepatitis C and VDRL. 22) Positive result for urinary screen test for drugs of abuse (amphetamines, morphine, benzodiazepines, marijuana, cocaine and barbiturate). 23) Subjects with positive test results for urine pregnancy test for female subjects. 24) History or presence of eas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate and extent of absorption of Empagliflozin 25 mg+ Metformin Hydrochloride 1000mg Extended Release Tablet of The ACME Laboratories Ltd with Synjardy XR Tablets (Empagliflozin 25 mg + Metformin Hydrochloride 1000 mg Extended Release Tablet) of Boehringer Ingelheim (BI) Pharmaceuticals, Inc., USA in healthy, adult, human subjects under fed conditionsTimepoint: To compare the rate and extent of absorption of Empagliflozin 25 mg+ Metformin Hydrochloride 1000mg Extended Release Tablet of The ACME Laboratories Ltd with Synjardy XR Tablets (Empagliflozin 25 mg + Metformin Hydrochloride 1000 mg Extended Release Tablet) of Boehringer Ingelheim (BI) Pharmaceuticals, Inc., USA in healthy, adult, human subjects under fed conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of the study subjects after administration of Empagliflozin 25 mg+ Metformin Hydrochloride 1000mg Extended-Release Tablet in healthy, adult, human subjects under fed conditions. Timepoint: Vital signs (blood pressure, pulse rate, respiratory rate and axillary/body temperature) measurement station Before check-in, at Pre-dose 0.00 (within 2.00 hrs before dosing), at 3.00, 7.00 and 11.00 hrs after dosing (within ± 60 min of scheduled time of recording), at the time of check-out in each period and each ambulatory visit in each period. The well-being of subjects will be ascertained at each vital sign measurement. | — |
Countries
India
Contacts
Public ContactDr Lakshmikar B V
ICBio Clinical Research Private limited
Outcome results
None listed