Bioavailability Comparison Study of Two Types of Nimodipine Injections in Healthy Volunteers

Safety Issues Clinical Trial

Official title: A Randomized, Open-label, Single Dose, Two Formulation, Two Period, Double Cross Over Bioavailability Comparison Study of Two Types of Nimodipine Injections in Healthy Volunteers

Status Recruiting

Clinical Trial Summary

A Randomized, Open-label, Single Dose, Two Formulation, Two Period, Double Cross Over Bioavailability Comparison Study of two types of Nimodipine Injections in Healthy Volunteers.

Clinical Trial Description

The investigation product Nimodipine Injection (II) was supplied by Shenyang Dongxing Pharmaceutical Technology Co., Ltd.And Nimodipine injection (trade name: Nimotop) manufactured by Bayer Pharma AG was used as the reference preparation.The volunteers were administered with Nimodipine injection for intravenous infusion (containing nimodipine 11 mg) for 12 consecutive hours, respectively.The Venous blood was collected at 0 hours before the administration (ie, 1 hour before the administration) and 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h (Administration was over) and 12.5 h, 13 h, 14 h, 16 h, 19 h, 22 h, 25 h, 36 h, 3 ml per blood collection. ;

Related Conditions & MeSH terms

• Bioavailability
• Cerebrovascular Disorders
• Ischemic Cerebrovascular Disease
• Safety Issues

• NCT number: NCT03794843
• Study type: Interventional
• Source: Shenyang Dongxing Pharmaceutical Technology Co., Ltd.
• Contact: Zhang Lan, Doctor
• Phone: +86-010-83198855
• Email: xwphase1@163.com
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 23, 2018
• Completion date: June 2019