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

NCT03794843 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-01-08

No results posted yet for this study

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.

Conditions

  • Bioavailability
  • Safety Issues
  • Ischemic Cerebrovascular Disease

Interventions

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

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • Shenyang Dongxing Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-23
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03794843 on ClinicalTrials.gov