MedTrace Logo

Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites

NCT05075876 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-02-09

No results posted yet for this study

Summary

This study is an open-label, single-center, two-period, two-sequence crossover study to assess the bioequivalence of SP-01 (Sancuso®: Granisetron Patch) manufactured at two different sites. Either the test product, namely SP-01-K, or reference product, namely SP-01-A, will be applied to the subject once in each period.

Conditions

  • Healthy Volunteers

Interventions

DRUG

SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron)

Single application for 6 days

DRUG

SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)

Single application for 6 days

Sponsors & Collaborators

  • Solasia Pharma K.K.

    lead INDUSTRY

Principal Investigators

  • Bernard Man Yung Cheung · Phase 1 Clinical Trials Centre, The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-10-13
Primary Completion
2021-12-03
Completion
2021-12-03

Countries

  • Hong Kong

Study Locations

More Related Trials

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 NCT05075876 on ClinicalTrials.gov