Bioequivalance
Conditions
Keywords
empagliflozin, bioequivalence
Brief summary
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
Detailed description
The study design was a randomized, open-label, two-way, crossover, single-dose, prospective, and longitudinal study, with a 7-day wash-out period before next dosing; to compare the pharmacokinetic profile (Cmax and AUC0-t) of two 25 mg empagliflozin tablet formulations in thirty-two (32) healthy Mexican adult volunteers aged 18 to 55 years.
Interventions
Reference. empagliflozin 25 mg tablet
Test. empagliflozin 25 mg tablet
Sponsors
ADIUM
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 55 years. 2. Clinically healthy according to the updated medical history prior to the start of the study. 3. Not blocked in the COFEPRIS research subject database. 4. Body mass index between 18 and 27 kg/m². 5. 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. 6. Electrocardiogram (ECG) without any signs of pathology. 7. Clinical laboratory test results within normal limits or with clinically insignificant variations. 8. Negative biosafety tests for the presence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and varicella-zoster virus (VDRL). 9. Negative drug screening tests for amphetamines, benzodiazepines, cocaine, methamphetamines, morphine, and tetrahydrocannabinol (THC). 10. Negative qualitative pregnancy test (for women). 11. Negative breath alcohol test. 12. Research subjects with no history of alcohol abuse or dependence, psychoactive substance abuse, or chronic medication use. 13. Subjects with a signed informed consent form and a signed non-pregnancy commitment letter. 14. Women who are not pregnant or breastfeeding. 15. Women using at least one method of family planning deemed safe by the principal investigator.
Exclusion criteria
1. Subjects with a history of hypersensitivity to the study drug. 2. Subjects with lactose intolerance. 3. 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. 4. Subjects requiring any medication during the course of the study that interferes with the quantification or pharmacokinetics of the study drug. 5. 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. 6. Subjects who, prior to receiving the study drug, have taken medications such as those described in section 3.11 "Drug Interactions." 7. 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. 8. Subjects who have received an investigational drug within ninety days prior to the start of the study. 9. Subjects who have donated or lost 450 mL or more of blood within sixty days prior to the start of the study. 10. Research subjects with a history of alcohol or psychoactive substance abuse or dependence, or chronic medication use. 11. Subjects who have consumed beverages or foods containing xanthines (coffee, tea, cocoa, chocolate, yerba mate, cola, etc.) or have consumed charcoal-grilled foods within 12 hours prior to administration of the medication dose. 12. Subjects who have consumed grapefruit, cranberry, or pomegranate juice within 12 hours prior to the study. 13. Subjects who have smoked at least 12 hours before the start of the study. 14. Subjects who have ingested alcoholic beverages 48 hours prior to administration of the dose. 15. Positive (qualitative) pregnancy test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bioequivalence based on the pharmacokinetic parameter: Cmax | Through 72 Hours Post Dose | Bioequivalence based on the pharmacokinetic parameter: Cmax |
| Bioequivalence based on the pharmacokinetic parameter: AUC0-t | Through 72 Hours Post Dose | Bioequivalence based on the pharmacokinetic parameter: AUC0-t |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterize the pharmacokinetic parameter: AUC0-inf | Through 72 Hours Post Dose | Characterize the pharmacokinetic parameter: AUC0-inf |
| Characterize the pharmacokinetic parameter: time to maximum concentration (tmax) | Through 72 Hours Post Dose | Characterize the pharmacokinetic parameter: time to maximum concentration (tmax) |
| Characterize the pharmacokinetic parameter: elimination constant (Ke) | Through 72 Hours Post Dose | Characterize the pharmacokinetic parameter: elimination constant (Ke) |
| Characterize the pharmacokinetic parameter: half-life (t1/2) | Through 72 Hours Post Dose | Characterize the pharmacokinetic parameter: half-life (t1/2) |
| Establish the frequency, severity, and seriousness of adverse events that occurred during the study. | Until the final visit (7 days after the last dose) | Establish the frequency, severity, and seriousness of adverse events that occurred during the study. |
Countries
Mexico
Outcome results
None listed