Bioequivalence Study of Empagliflozin And Linagliptin Tablets in Healthy Chinese Subjects (NCT05956522) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence Study of Empagliflozin And Linagliptin Tablets in Healthy Chinese Subjects
China106 participantsStarted 2022-07-01
Plain-language summary
To investigate the pharmacokinetics of the test and the reference preparation Empagliflozin And Linagliptin Tablets in healthy adult subjects by single oral administration in fasting/postprandial state, and to evaluate the bioequivalence of the two oral preparations in fasting/postprandial state.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 1\. Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions; 2. Be able to complete the study according to the requirements of the test plan; 3. Subjects (including male subjects) agreed to have no pregnancy plan and to voluntarily take effective contraceptive measures within 3 months from the end of the study after signing the informed consent; 4. Male and female subjects aged 18 years and above; 5. Male subjects weigh at least 50kg. Female subjects weighed at least 45 kilograms. Body Mass index = weight (kg)/height 2 (m2), within the range of 19.0 to 27.0kg/m2 (including the critical value)
Exclusion Criteria:
* 1.History of specific allergies (urticaria, exfoliative dermatitis, angioedema or bronchial hypersensitivity), or allergies (e.g., allergy to two or more medications, foods such as milk and pollen), or known allergy to components of the drug or its analogues; 2. Those with a history of serious diseases such as cardiac, hepatic, renal, gastrointestinal, neurological, endocrine, respiratory and mental abnormalities, etc., which are considered inappropriate by the investigating doctor; 3. Abnormalities of clinical significance as determined by the clinician, including physical examination, vital signs, electrocardiogram or clinical laboratory tests.
4\. Previous or current history of pancreatitis; 5. Estimated glomerular filtration rate (eGFR) \<90 mL/min/1.73 m2; 6. History of dys…
What they're measuring
1
Peak Plasma Concentration (Cmax)
Timeframe: 72hours
2
Area under the plasma concentration versus time curve (AUC0-t)
Timeframe: 72hours
3
Area under the plasma concentration versus time curve (AUC0-∞)
Timeframe: Infinite Time
4
Area under the plasma concentration versus time curve (AUC0-72h)
Timeframe: 72hours
Trial details
NCT IDNCT05956522
SponsorThe Affiliated Hospital of Qingdao University