Completed PHASE1 INTERVENTIONAL 2-arm 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

Sponsor: Solasia Pharma K.K.

Conditions Healthy Volunteers

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

Updated 5 times since 2021 Last updated: Feb 7, 2022 Started: Oct 13, 2021 Primary completion: Dec 3, 2021 Completion: Dec 3, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05075876, this PHASE1 trial focuses on Healthy Volunteers and remains completed. Sponsored by Solasia Pharma K.K., it has been updated 5 times since 2021, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Mar 2022 — Jul 2024 [monthly]

Completed PHASE1

Status: Active Not Recruiting → Completed
Jan 2022 — Mar 2022 [monthly]

Active Not Recruiting PHASE1

Status: Recruiting → Active Not Recruiting
Nov 2021 — Jan 2022 [monthly]

Recruiting PHASE1

First recorded

Oct 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Solasia Pharma K.K.

Data source: Solasia Pharma K.K.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Hong Kong, Hong Kong