NCT05075876

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

An Open-Label, Randomized, Single-Center, Two-period, Two-sequence Cross-over Study to Assess the Bioequivalence of a Single 6-day Application of SP-01 (Granisetron Patch) Manufactured at Two Different Sites in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Solasia Pharma K.K. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-10-13
• Primary completion: 2021-12-03
• Completion: 2021-12-03
• First posted: 2021-10-13
• Last updated: 2022-02-09

Locations

1 site across 1 country: Hong Kong