Empagliflozin 10 mg Tablets Relative to Jardiance 10 mg

Launched by BIO-INNOVA CO., LTD · Jan 22, 2024

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ClinConnect Summary

This clinical trial aims to compare how well two different forms of the medication Empagliflozin (10 mg tablets) are absorbed in the body. This study will involve healthy individuals between the ages of 18 and 55. Participants will take both the generic and the reference version of the medication in separate sessions, with a break of at least seven days between doses. The goal is to see if there are any differences in how the body handles these two versions of the drug.

To be eligible for this study, participants need to be in good health, have a Body Mass Index (BMI) between 18.5 and 30, and be willing to provide consent and undergo blood tests. However, individuals with certain medical conditions, allergies to the medication, or those taking other medications recently may not qualify. If you decide to join, you can expect close monitoring for safety throughout the study, along with guidance on lifestyle factors like diet and alcohol consumption that could affect the results. This trial is not yet recruiting, so if you are interested, keep an eye out for updates on when it will begin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Willingness to provide written informed consent prior to participate in the study.
• • 2. Healthy Thai subjects are between 18 to 55 years of age.
• • 3. The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2.
• • 4. Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects' safety after the completion of the study.
• • 5. Negative urine pregnancy test for women and no breast-feeding.
• • 6. Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.
• Exclusion Criteria:
• • 1. History or evidence of allergy or hypersensitivity to Empagliflozin or any related drugs or any of the excipients of this product.
• • 2. Subject with B.P. is Systolic B.P \< 90, ≥140 mm/Hg, Diastolic B.P \< 60, ≥90 mm/Hg, pulse rate \> 100 beats per minute.
• • 3. Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).\*
• • 4. Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).\*
• • 5. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).\*
• • 6. Positive of hepatitis B or C virus or HIV
• • 7. Have more than one abnormal EKG, which is considered as clinically significant. \*
• • 8. History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension or glaucoma
• • 9. Creatinine clearance less than 60 mL/min
• • 10. History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
• • 11. Any major illness in the past 3 months or any significant ongoing chronic medical illness.
• • 12. History that may predispose to ketoacidosis including pancreatic insulin deficiency from any cause or severe starvation within past 1 month.
• • 13. History of psychiatric disorder.
• • 14. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
• • 15. History of usually smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of the study.
• • 16. High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
• • 17. Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids).
• • 18. Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-Provera must be discontinued at least 6 months) prior to the study drug administration and until the completion of each period of the study.
• • 19. History of difficulty in accessibility of veins in left and right arm.
• • 20. Blood donation (one unit or 450 mL) within the past 3 months before the study.
• • 21. Participation in any clinical study within the past 3 months before the study.
• • 22. Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
• • (\* Depend on decision of principal investigator and/or clinical investigator)