a single-center, open, randomized, single-dose, cross-over bioequivalence study to evaluate the effects of the test formulation abalparatide injection and the reference formulation abalparatide injection (tymlos®) in healthy adult subjects

Conditions: Osteoporosis

Summary: to investigate the pharmacokinetics of the test preparation abalparatide injection and the reference preparation abalparatide injection (tymlos®) in healthy adult subjects under fasting state, and to evaluate the bioequivalence of the two formulations under fasting state.


Eligibility criteria:
inclusion criteria: * 1. before the test, voluntarily sign informed consent, fully understand the test content, process and possible adverse reactions, and complete the study according to the requirements of the test plan; 2. female subjects have taken effective contraceptive measures within 14 days before the first dose (self-screening period for male subjects) and are willing to have no pregnancy, sperm donation or egg donation plan from signing informed to 6 months after the last dose, and voluntarily take effective contraceptive measures, specific contraceptive measures are shown in appendix 2; 3. male and female subjects aged 40 to 65 years (including boundary values); 4. male subjects weigh no less than 50.0kg, female subjects weigh no less than 45.0kg, body mass index in the range of 19.0\~28.0 kg/m2 (including the critical value). exclusion criteria: * 1. have a history of serious diseases such as heart, liver, kidney, digestive tract, nervous system, endocrine system, respiratory system and mental disorders, which are considered unsuitable by the study doctor; 2. clinically significant abnormalities judged by clinicians, including physical examination, vital signs examination, electrocardiogram or clinical laboratory examination; 3. currently suffering from allergic diseases (urticaria, asthma, etc.), or allergies (such as allergies to two or more drugs, foods such as milk or pollen), or known allergies to components or analogues of the drug; 4. patients with hyperparathyroidism, paget's disease or history; 5. past or present postural hypotension or dizziness in the morning; 6. hyperuricemia (including previous history of gout), hypercalcemia or active urinary calculus; 7. serum calcium higher than the upper limit of normal, or creatinine clearance \ 400ml, except for female physiologic blood loss), or donated platelets ≥2 therapeutic amounts (1 therapeutic amount =12u platelets) within 1 month; 16. participants in any drug clinical trial and administration within 3 months before the first dose; 17. those who have received any prescription drugs (including vaccines) within 14 days prior to the first dose; 18. those who have received any over-the-counter medicines (including birth control pills), chinese herbs or health products (including vitamins) within 7 days before the first dose; 19. ngested any food rich in xanthines (such as coffee, tea, chocolate, cocoa, milk tea, etc.), grapefruit (grapefruit), pomelo, pomegranate, lime, star fruit and its products, or had intense exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.; 20. patients with difficulty in venous blood collection or a history of fainting needles and fainting blood, or skin scars, wounds or tattoos at the injection site, which affect the absorption or observer of injection drugs; 21. subjects deemed unsuitable for participation by other investigators.