Bioequivalence study of an open-label, randomized, two-way crossover design with two-period, two-treatment, two-sequence of test product empagliflozin 25 mg film-coated tablets and reference product (Jardiance 25 mg) in Thai healthy volunteers under fasting conditio
- Conditions
- Healthy volunteers
- Registration Number
- TCTR20230906005
- Lead Sponsor
- Pharmacy Service Center, Faculty of Pharmacy, Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 28
1)Healthy Thai male and female subjects based on their medical history and physical examination, aged between 20-45 years, using the age at the time of informed consent based on their birthday given.
2)Normal or not clinically significant abnormal of laboratory results including blood urea nitrogen (BUN), serum creatinine (SCr), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, total protein, fasting blood glucose, complete blood count, and urinalysis.
3)Negative hepatitis B test result.
4)Not clinically significant findings in vital sign measurement.
5)Body weight of at least 45 kg with Body Mass Index (BMI) between 18.5-30.0 kg/m2
6)Females who participate in this study must meet the following criteria:
6.1) Have a negative pregnancy test and be nonpregnant.
6.2) Not be currently breastfeeding.
6.3) Abstain from using any form of hormonal contraceptive method, including oral contraceptive or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone releasing intrauterine devices (IUDs), or postcoital contraception, and hormone replacement therapy for at least 28 days prior to admission in period 1. Injectable contraceptives must have been discontinued at least 6 months prior to admission in period 1. Female subjects who do not have childbearing potential must meet at least one of the following criteria before admission in period 1:
-Post menopausal for at least 1 year or
-Surgically sterile (bilateral ligation, bilateral oophorectomy or hysterectomy) at least 6 months
6.4) Female subjects who have childbearing potential must use an acceptable non-hormonal contraceptive method for at least two weeks before admission in period 1 until 7 days after the end of the study in period 2, as judged by the clinical investigators. Acceptable non-hormonal contraceptive methods include condoms, non-hormonal IUDs, or being willing to remain abstinent (not engage in sexual intercourse).
7) Subjects who are willing to comply with the study procedures and restrictions.
1)Subjects with a history of allergy to empagliflozin or related structures or any component of the product.
2)Subjects with current or history of alcohol addiction or drug abuse.
3)Subjects with any evidence or current clinically significant conditions of asthma, lung disease, seizures, hepatic, renal, endocrine, or cardiovascular diseases or any other conditions that may affect bioavailability of the studied medication or the safety of the subjects.
4)Subjects who have a high risk of COVID-19 infection based on a risk assessment questionnaire or who test positive for COVID-19.
5)Subjects who have a history of using tobacco or nicotine containing product within the six months before admission in period 1 and unable to abstain from their use during the study.
6)Subjects who have taken any medications including vitamins, minerals (e.g., iron), herbal products (e.g., St. Johns wort), or dietary supplement within 14 days before admission in period 1 and cannot discontinue them during the study.
7)Subjects who have consumed orange or pomelo or grapefruit or any products containing these fruits within 7 days before admission in period 1 and are unable to discontinue them during the study.
8)Subjects who have ingested caffeinated beverages and foods, including tea, coffee, cocoa, cola, chocolate, or energy drinks, within 3 days prior to admission in period 1 and are unable to cease their consumption during the study.
9)Subjects who test positive for methamphetamine, cannabinoid, or opiates in a urine drug abuse test.
10)Subjects with a positive alcohol breath test.
11)Subjects who have undergone surgery or blood donation greater than 300 mL or experienced significant blood loss within 90 days prior to the initiation of the study.
12)Subjects who have participated in other clinical trials within 90 days before the initiation of this study.
13)Subjects who are unable to communicate effectively, such as those with language difficulties, poor mental development, psychiatric illness, or impaired cerebral function, which may hinder their ability to provide written informed consent or cooperate with the clinical team.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Empagliflozin 0.0 -72.0 h AUC0-t, AUC0-inf, and Cmax
- Secondary Outcome Measures
Name Time Method Safety at the beginning , during and at the end of the trial. clinical and laboratory examinations