The Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Conducted in Chinese healthy adult volunteers,the study aims to observe the safety and tolerability of single/multiple-dose administration of different doses of Alprostadil Liposome for Injection as well as to confirm the safety dose range.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD
• Treatments: Alprostadil

Criteria

Inclusion Criteria:

• Healthy volunteers are at least 20 years of age and no older than 40.

• BMI are at least 19.0kg/m2,and no more than 24.0kg/m2.(The weight is greater than or equal to 50kg.)Subjects who are overweight or underweight will not be inclusion.

• Subjects with normal heart rate( 60-100 beats per minute) as well as normal blood pressure(systolic blood pressure:90-120 mmHg;diastolic blood pressure:60-90 mmHg).

• 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.

• Given their signed written informed consent to participate.

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 in the past 2 years.

• 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 200ml 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 were in the mentrual period.

• Women who are pregnant or lactating.