Bioequivalence
Conditions
Interventions
Experimental:limaprost tablets 10ug (2 tablets, 5µg/tablet)
Active Comparator:limaprost tablets (OPALMON) 10ug (2 tablets, 5ug/tablet)
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions; 2. Be able to complete the study according to the requirements of the trial protocol; 3. The subjects (including their partners) are willing to have no birth plan and voluntarily take effective contraceptive measures in the next 6 months. See the appendix for specific contraceptive measures; 4. Male and female subjects aged 18 to 65 (including 18 and 65 years old); 5. The weight of male subjects shall not be less than 50kg, and that of female subjects shall not be less than 45kg. Body mass index (BMI) = body weight (kg) /height 2(m2), in the range of 18~28kg/m2 (including the critical value); 6. State of health: no history of clinical significance such as heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders and metabolic abnormalities; 7. Physical examination and vital signs are normal or abnormal but without clinical significance.
Exclusion criteria
Exclusion criteria: 1. Those who smoked more than 5 cigarettes per day 3 months before the trial; 2. Have a history of allergy to limaprost, or have allergic constitution (allergy to various drugs); 3. Have a history of excessive drinking (14 units of alcohol per week: 1 unit=285 mL of beer, or 25mL of spirits, or 100mL of wine); 4. Have donated blood or had massive blood loss (> 450mL) within three months before screening; 5. Have taken drugs that can change liver enzyme activity 28 days before screening; 6. Have taken any prescription drugs and over-the-counter drugs, and any vitamin products or herbal medicine within 14 days before screening; 7. Have taken special foods (including pitaya, mango, pomelo, etc.) or had vigorous exercise or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before screening; 8. Combined with the following inhibitors or inducers with the CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; 9. Significant changes in diet or exercise habits recently; 10. Have taken a study drug or participated in a drug clinical trial within three months before taking the study drug; 11. Have a history of dysphagia or any gastrointestinal disease affecting drug absorption; 12. Suffer from any disease that increases the risk of bleeding, such as haemorrhoid, acute gastritis or gastric and duodenal ulcer; 13. Subjects who could not tolerate the standard meal (two boiled eggs, a piece of butter bacon toast, a box of fried potato chips, a cup of whole milk) (this rule only applies to the subjects participating in the postprandial trial); 14. Abnormal ECG with clinical significance; 15. Female subjects are in lactation or have positive pregnancy results in serum during screening period or trial; 16. Clinically significant abnormalities in clinical laboratory examinations, or other clinical findings showing clinically significant diseases (including but not limited to the gastrointestinal tract, kidney, liver, nerves, blood, endocrine, tumor, lung, immune, mental or cardiovascular disease); 17. Viral hepatitis (including hepatitis B and C), and AIDS antibody and treponema pallidum antibody screening positive; 18. Suffer from acute disease or have taken the concomitant medication from the screening stage to the pre-study drug taking; 19. Have taken chocolate, any caffeinated or xanthine-rich food or drink 48 hours before taking the study drug; 20. Have taken any alcoholic product within 48 hours before taking the study drug; 21. Those who are positive in urine drug test or have drug abuse history or have taken drugs in the past five years; 22. The investigators believe that there are other factors that are not suitable for the people to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Limaprost in Plasma; | — |
Countries
China
Contacts
Public ContactVincent
Beijing Tide Pharmaceutical Co., Ltd.
Outcome results
None listed