Lower Extremity Arterial Occlusive Diseases Clinical Trial
Official title:
The Safety, Tolerability and Pharmacokinetic Phrase I Study of Alprostadil Fat Emulsiom Injection in Healthy Adult Volunteers
Conducted in Chinese healthy adult volunteers,the study aims to observe the safety, tolerability and pharmacokinetic of single-dose administration of different doses of Alprostadil Liposome for Injection as well as to confirm the safety dose range.
| Status | Recruiting |
| Enrollment | 48 |
| Est. completion date | October 30, 2018 |
| Est. primary completion date | October 15, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Healthy volunteers are at least 18 years of age and no older than 40. - BMI are at least 19.0kg/m2,and no more than 24.0kg/m2.(The male weight is greater than or equal to 50kg.The female weight is greater than or equal to 50kg.)Subjects who are overweight or underweight will not be inclusion. - Subjects with normal medical history,vital signs,physical examination and clinical examination (routine blood,routine urine,blood chemistry,coagulation function and ECG,X-ray,intraocular pressure and so on). - A negative hepatitis B surface antigen,hepatitis C,HIV or syphilis test result. - Subjects with the ability to communicate with investigators.Besides,subjects must be willing to remain at the study center as required per protocal to complete all visit assessments. Exclusion Criteria: - Subjects have brain dysfunction,mental development disorders or speech disorders that unable to communicate with investigators. - Subjects with a history of psychiatric disease or drug dependence. - Subjects with a medical history about cardiac,liver,renal,digestive system or neurological. - Subjects with the family history of diabetes,the history of pancreatitis,cholelithiasis or asthma. - Subjects significantly abuse alcohol or tobacco. - Drink in 24 hours before post-dosing of study drug. - Subjects who had taken medications within 2 weeks. - Subjects who had suffer from exsanguine or donated blood over 400ml within 3 months will be excluded. - Subjects who participate in other clinical trials within 3 months will be excluded. - History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes. - Subjects with a history of fainting. - Subjects who had infected for unknown reason. - Subjects with interstitial pneumonia. - Subjects with glaucoma or intraocular pressure with hyperthyroidism. - Women who are pregnant or lactating. |
| Country | Name | City | State |
|---|---|---|---|
| China | Xuhuiqu central hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 | 8 days |