NCT03794843

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

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: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Shenyang Dongxing Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Bioavailability
• Safety Issues
• Ischemic Cerebrovascular Disease

Interventions

Type	Name	Description
DRUG	Nimodipine Injection	Nimodipine injection (trade name: Nimotop) manufactured by Bayer Pharma AG was used as the reference preparation
DRUG	Nimodipine Injection (II)	Nimodipine Injection (II) was supplied by Shenyang Dongxing Pharmaceutical Technology Co., Ltd

Timeline

• Start date: 2018-08-23
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2019-01-07
• Last updated: 2019-01-08

Locations

1 site across 1 country: China