Bioavailability Assessment of Empagliflozin 25 mg Film-Coated Tablets: Single-Dose, Open-Label, Randomized Crossover Study in Healthy Subjects Under Fasting Conditions
- Trial ID
- 2023-506416-41-00
- Protocol
- BLCL-EMP-PIL01
Trial statistics
Objectives
The primary objective of this study is to evaluate the **bioavailability** of Empagliflozin 25 mg film-coated tablets in healthy subjects under fasting conditions. This is a critical assessment as it determines the extent and rate at which the active drug ingredient is absorbed and becomes available at the site of action. Understanding the bioavailability of Empagliflozin is clinically relevant as it informs dosing regimens and ensures therapeutic efficacy in managing conditions for which the drug is indicated. No secondary objectives are specified for this study.
Participants
The clinical trial involves a study population that includes both **male** and **female** participants, with an age range categorized as 3, which typically corresponds to adults. The trial does not focus on any specific **medical condition**, as indicated by the absence of a targeted condition. The sponsor has not provided information regarding the total number of participants involved in the study. The trial population selection criteria include a vulnerable population, although specific details on lifestyle considerations such as diet, physical activity, or habits have not been disclosed. The sponsor has not provided key inclusion or exclusion criteria for this trial.
Plans and Procedures
The clinical trial is designed as a **randomized**, open-label, two-sequence, two-treatment, two-period crossover study to evaluate the **bioavailability** of Empagliflozin 25 mg film-coated tablets in healthy subjects under fasting conditions. The trial is categorized as a Phase 2 study and does not involve any specific medical condition. The estimated recruitment start date is August 23, 2023, with an anticipated end date of September 30, 2023, indicating a relatively short overall trial duration.
Participants will undergo a sequence of study visits, beginning with an inclusion visit, also known as the screening visit, to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into one of two sequences for the crossover design. Each participant will receive two treatments in two separate periods, with a washout phase in between to ensure no carryover effects. The purpose of these visits is to collect data on the pharmacokinetic profile of the drug under investigation.
Follow-up visits will be scheduled to monitor participants for any adverse events and to ensure compliance with the study protocol. The end-of-study visit will conclude the trial, where final assessments will be conducted, and data will be collected for analysis. The expected length of participant involvement is approximately one month, considering the crossover design and washout period. Conditions that may lead to early termination from the study include non-compliance with the study protocol, withdrawal of consent, or the occurrence of any adverse events that compromise participant safety.
Treatment
The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.
Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included.
Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.
Efficacy
The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to begin recruitment on August 23, 2023, with an estimated end date of September 30, 2023. The efficacy assessment will focus on specific endpoints, although these are not detailed in the provided data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methods and tools for measuring efficacy, as well as the specific parameters or endpoints, are not specified in the available information. The trial will adhere to standard clinical trial protocols to evaluate the efficacy of the intervention under investigation.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Free written informed consent prior to any procedure required by the study.
- Male or female subject between 18 and 55 years, inclusive, at the time of signing the informed consent.
- Body mass index (BMI) of 18.5 to 30.0 kg/m2, inclusive.
- No clinically relevant diseases captured in medical history.
- No clinically relevant abnormalities on physical examination.
- No clinically relevant abnormalities on 12-lead ECG.
- No clinically relevant abnormalities on clinical laboratory tests.
- Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAG) and anti-Hepatitis C virus antibodies (anti-HCVAb)
- Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening)
- Willingness to accept and comply with all study procedures and restrictions.
- A female subject is eligible if she meets one of the following criteria: a) is of non-childbearing potential; or b) is of childbearing potential and agrees to use an accepted contraceptive method from at least 4 weeks prior to admission to the first study period until 2 weeks after the end of the study.
Exclusion Criteria
- Known hypersensitivity / allergy reaction to the study drug substance or any of the excipients of the investigational medicinal products (lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, Hypromellose, calcium carbonate, titanium dioxide [E171], talc, macrogol [400], iron oxide yellow [E172]).
- Known rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- Known severe hypersensitivity reaction to any other drug.
- Any medical condition (e.g., gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (e.g., cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject safety.
- History of diabetes.
- History of cardiovascular disease.
- History of pancreatitis.
- History of renal or hepatic impairment.
- History of orthostatic hypotension, collapse, fainting, syncope, or vasovagal reaction.
- Systolic blood pressure (SBP) <90 mmHg and/or diastolic blood pressure (DBP) <45 mmHg, measured on the dominant arm, after at least 3 minutes in seated position.
- Serum transaminases alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range.
- Estimated renal creatinine clearance (CLCr) below the lower limit of normal range, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m2.
- Positive result in drugs-of-abuse or ethanol tests.
- Use of a depot injection or an implant of any drug (except for contraceptives) within the previous 6 months.
- Average weekly alcohol consumption of >14 units for males and >7 units for females within the previous 6 months.
- Average daily consumption of methylxanthines-containing beverages or food (e.g., coffee, tea, cola, sodas, chocolate) equivalent to >500 mg of methylxanthines.
- Participation in any clinical trial within the previous 2 months.
- Participation in more than 2 clinical trials within the previous 12 months.
- Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months.
- Difficulty in fasting or any dietary restriction such as lactose intolerance, vegan, low-fat, low sodium, etc., that may interfere with the diet served during the study.
- Veins unsuitable for intravenous puncture on either arm.
- Difficulty in swallowing capsules or tablets.
- If woman, positive pregnancy test in serum.
- If woman, she is breast-feeding.
- Any other condition that the Investigator considers to render the subject unsuitable for the study.
- Any recent disease or condition or treatment that, according to the Investigator, would put the subject at undue risk due to study participation or occurred at a timeframe in which may interfere with the pharmacokinetics of study drug.
- Use of prescription or nonprescription medicinal products, vitamins, food supplements or herbal supplements (including St John’s Wort) within the previous 2 weeks, unless in the Investigator’s opinion the medication does not interfere with the pharmacokinetics of study drug or compromise subject safety.
- Positive result in drugs-of-abuse or ethanol tests.
- Consumption of products containing xanthines (for example, coffee, tea, chocolate, cola beverages and energy drinks) within the previous 48 hours before each study drug administration.
- Consumption of pineapple, Seville oranges, pomelo, pomegranate, starfruit or grapefruit products (fresh, canned, or frozen) within the previous week.
- If woman, positive pregnancy test in serum or urine.
- Any other condition that the investigator considers to render the subject unsuitable for the study period.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Portugal | Not Recruiting | 23 Aug 2023 | 16 |
Sites & Investigators
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Empagliflozin 25 mg film-coated tablets | Test | FILM-COATED TABLET | ORAL USE | 25 | 1 | PRD10425219 |
Jardiance 25 mg film-coated tablets | Comparator | FILM-COATED TABLETS | ORAL USE | 25 | 1 | PRD1594905 |