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PK, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and IV Granisetron

NCT00873197 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-06-17

No results posted yet for this study

Summary

This study has been designed to investigate the pharmacokinetic and safety profile of the co-administration of intravenous (IV) and transdermal granisetron, as well as characterise the pharmacokinetics of multiple transdermal dosing.

Conditions

  • Healthy

Interventions

DRUG

granisetron

Sancuso® 3.1 mg/24 hours; transdermal. One patch applied to healthy intact skin on the upper outer arm and worn for 7 days (168 hours) followed by a second patch applied to the opposite arm at 168 hours for a further 7 days (168 to 336 hours). Kytril® (granisetron hydrochloride) 1 mg/mL; IV; 0.01 mg/kg (maximum 1 mg) administered over 30 seconds immediately following patch application on Day 1 only.

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Stuart J Mair · Syneos Health

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United Kingdom

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 NCT00873197 on ClinicalTrials.gov