Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformi… (NCT07633015) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 5 mg / 850 mg Tablets Under Fed Conditions.
Mexico42 participantsStarted 2025-02-17
Plain-language summary
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age between 18 and 55 years.
. Clinically healthy according to the updated medical history prior to the start of the study.
. Not blocked in the COFEPRIS research subject database.
. Body mass index between 18 and 27 kg/m².
. Normal vital signs: Heart rate between 60 and 99 beats per minute, respiratory rate between 12 and 20 breaths per minute, systolic blood pressure between 90-130 mmHg, diastolic blood pressure between 60-89 mmHg, and temperature between 36.0 and 37.4°C.
. Electrocardiogram (ECG) without any signs of pathology.
. Clinical laboratory test results within normal limits or with clinically insignificant variations.
. Negative biosafety tests for the presence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and varicella-zoster virus (VDRL).
Exclusion criteria
. Subjects with a history of hypersensitivity to the study drug.
. Subjects with lactose intolerance.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bioequivalence based on the pharmacokinetic parameter: Cmax
Timeframe: Through 48 Hours Post Dose
2
Bioequivalence based on the pharmacokinetic parameter: AUC0-t
. Subjects with a history of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurological, endocrine, hematopoietic (any type of anemia), mental illness, or other organic abnormalities that could affect the pharmacokinetic study of the study product.
. Subjects requiring any medication during the course of the study that interferes with the quantification or pharmacokinetics of the study drug.
. Subjects who have been exposed to agents known to induce or inhibit hepatic enzyme systems or who have taken potentially toxic medications within 30 days prior to the start of the study.
. Subjects who, prior to receiving the study drug, have taken medications such as those described in section 3.11 "Drug Interactions."
. Subjects who have been hospitalized for any reason within sixty days prior to the start of the study or who have been seriously ill within thirty days prior to the start of the study.
. Subjects who have received an investigational drug within ninety days prior to the start of the study.