CompletedNot Applicable

Bioequivalence Study of EMPAGLIFLOZIN (25 mg Tablets) vs. JARDIANCE® (25 mg Tablets), in Healthy Research Subjects, Under Fasting Conditions

Mexico32 participantsStarted 2024-11-29

Plain-language summary

Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. Subjects with a history of hypersensitivity to the study drug.
✕. Subjects with lactose intolerance.
✕. 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.

Bioequivalence based on the pharmacokinetic parameter: Cmax

Timeframe: Through 72 Hours Post Dose

Bioequivalence based on the pharmacokinetic parameter: AUC0-t

Timeframe: Through 72 Hours Post Dose

NCT IDNCT07479108

SponsorADIUM

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-11

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).

✕. Subjects with a history of hypersensitivity to the study drug.
✕. Subjects with lactose intolerance.
✕. 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.