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Study of Granisetron Hydrochloride Nasal Spray (GNS) in Healthy Volunteers

NCT02563951 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-01-08

No results posted yet for this study

Summary

The purpose of this study is to examine the pharmacokinetics (PK), safety and tolerability of 3 intranasal (IN) doses (0.5, 1.0 and 2.0 mg) of Granisetron Hydrochloride Nasal Sprays (GNS) as compared to Granisetron IV Injection and Granisetron Tablet in healthy Volunteers.

Conditions

Interventions

DRUG

GNS Spray 0.5mg

DRUG

GNS Spray 1.0mg

DRUG

GNS Spray 2.0mg

DRUG

Kytril 1mg (IV injection)

DRUG

Kytril 1mg (Tablet)

Sponsors & Collaborators

  • Tri-Service General Hospital

    collaborator OTHER

  • Maxinase Life Sciences Ltd.

    lead INDUSTRY

Principal Investigators

  • Kai-Min Chu, M.D Ph.D. · Tri-Service General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT02563951 on ClinicalTrials.gov