The study is conducted in healthy Thai human volunteers in bioequivalence study of Diabetes medicine Empagliflozin and metformin, bioequivalence study
Conditions
Interventions
The new generic products which were recently developed. Volunteer will receive a single-dose of empagliflozin/metformin FCT 12.5/1000 mg of either test or reference with 240 mL of water.,The marketed
Experimental Drug,Active Comparator Drug
Empamet 12.5/1000,Jardiance duo 12.5/1000
Sponsors
Unison Laboratories Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Thai male or female volunteers aged between 18 and 55 years. 2. The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2. 3. Determined healthy by medical history, physical examination and vital signs 4. The results of the clinical laboratory tests are within clinically acceptance limits i.e., blood urea nitrogen (BUN), serum creatinine, AST, ALT, total bilirubin, alkaline phosphatase, GGT, blood potassium, sodium, calcium, chloride, fasting blood sugar and hematology examinations including differential blood counts and HBsAg test. Some of the clinical laboratory values that out of the normal range will be carefully considered by clinical investigator. 5. Negative pregnancy test for female volunteers and effective contraceptive must be used at least 14 days prior to the study initiation and not breast-feeding women. 6. Male volunteers who are surgically sterile or agree to use an effective contraception throughout the study. 7. Willing to participate in the study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History or evidence of allergy or hypersensitivity to empagliflozin and/or metformin or any of the excipients of this product or any related drugs. 2. History or evidence of allergy or hypersensitivity to heparin. 3. History or evidence of hypertension (systolic BP < 140 mmHg, diastolic BP > = 90 mmHg) or hypotension (systolic BP <90 mmHg, diastolic BP <60 mmHg). 4. History or evidence of gastrointestinal, hepatic, renal, cardiovascular, hematological disease or allergic disease or bronchial asthma or any disease that may affect the bioavailability of drug. 5. History or evidence of metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis). 6. Evidence of more than one abnormal ECG which is considered as clinically significant. 7. History of chronic or debilitating diseases. 8. Positive HBsAg tests. 9. History of alcoholism or drug abuse. 10. Positive urine drug abuse tests (Benzodiazepines, Methamphetamine and Opiates). 11. History of regular alcohol consumption (more than 1 time a week) or alcohol consumption within 7 days prior to the study drug administration and until the completion of the study. 12. History of smoking more than 10 cigarettes/day, or moderate smokers (less than 10 cigarettes/day) and could not quit at least 7 days prior to the study drug administration and until the completion of the study. 13. Tea/coffee or caffeine- or xanthine-containing beverage consumption within 7 days prior to the study drug administration and until the completion of the study. 14. Grapefruit juice or grapefruit-containing products consumption within 7 days prior to the study drug administration and until the completion of the study. 15. Use of any prescription drugs or over-the-counter (OTC) drugs or herbal medicines within 30 days or vitamins or food supplements within 14 days prior to the study drug administration or use hormonal methods of contraception within 28 days (discontinuation for at least 6 months is required for Depo-Provera use) prior to receiving the first dose of the study medication. 16. Blood donation or blood loss over 350 mL within 90 days before the study. 17. Participation in any clinical studies within 90 days before the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC 0-t and AUC 0-inf 0, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 12.0, 24.0 and 48.0 hours Empagliflozin and metformin plasma concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax T1/2 and Kel 0, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 12.0, 24.0 and 48.0 hours Empagliflozin and metformin plasma concentration,Safety; Adverse events 0, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours Safety monitoring, vital sign, DTX | — |
Countries
Thailand
Contacts
Public ContactChaveewan Ratanajamit
Clinical and Pharmacological Research Unit Faculty of Pharmaceutical Sciences Prince of Songkla University
Outcome results
None listed