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Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches.

NCT05027646 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-06-14

No results posted yet for this study

Summary

The study is designed to evaluate the BE and adhesion properties of granisetron transdermal patches manufactured at 2 different sites. The study has been designed in accordance with the FDA Guidance for Industry. Bioequivalence will be based on the Cmax and AUC to determine the peak and total drug exposure, respectively.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Sancuso - Part 1

Part 1 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors.

DRUG

Sancuso - Part 2

Part 2 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors.

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Kyowa Kirin, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2021-12-22
Completion
2022-01-19
FDA Drug
Yes

Countries

  • United States

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 NCT05027646 on ClinicalTrials.gov