A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of EMPAGLIFLOZIN FILM-COATED TABLETS 25 mg relative to JARDIANCE (EMPAGLIFLOZIN FILM-COATED TABLETS 25 mg) in healthy Thai volunteers under fasting conditio
- Conditions
- Healthy subjectsBioequivalence EMPAGLIFLOZIN 25 mg
- Registration Number
- TCTR20230510004
- Lead Sponsor
- Bio-innova Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 26
1.Healthy Thai subjects are between 18 to 55 years of age.
2.The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2.
3.Healthy, no history of evidence of chronic disease or severe disorder.
4.No history of usually smoking (more than 10 cigarettes per day within past 1 year).
5.No history of alcoholism (more than 2 years).
6.Negative pregnancy test for women and no breast-feeding.
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.
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.History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
10.Any major illness in the past 3 months or any significant ongoing chronic medical illness.
11.History that may predispose to ketoacidosis including pancreatic insulin deficiency from any cause or caloric restriction.
12.History of psychiatric disorder.
13.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.
14.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.
15.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.
16.Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids).
17.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.
18.History of difficulty in accessibility of veins in left and right arm.
19.Blood donation (one unit or 450 mL) within the past 3 months before the study.
20.Participation in any clinical study within the past 3 months before the study.
21.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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax AUC0-t and AUC0-inf 0.00, 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00 and 48.00 hours post-dose Pharmacokinetics parameter
- Secondary Outcome Measures
Name Time Method Safety; Adverse events 0.0, approximately 1.0, 2.0, 4.0, 12.0, 24.0, 36.0 and 48.0 hours post-dose for vital sign and 0.0, approximately 2.0, 24.0, 36.0 and 48.0 hours post-dose for DTX Safety monitoring, vital sign, DTX