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NCT05027646 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches.
A Phase 1 study of Healthy Volunteers, sponsored by Kyowa Kirin.
- Completed
- Registry status
- Phase 1
- Development phase
- 134
- Enrollment target
- 1
- Study location
NCT05027646: Completed Phase 1 study of Healthy Volunteers, sponsored by Kyowa Kirin.
NCT05027646 is a Phase 1 study of Healthy Volunteers that has completed, run by Kyowa Kirin. The registered enrollment target is 134 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05027646, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Kyowa Kirin.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 134 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
AUC from time 0 to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule
Conditions Studied
Interventions
- DRUG Sancuso - Part 1
- DRUG Sancuso - Part 2
Study Locations (1)
Texas
- PPD Development - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2021-07-06 |
| Est. Completion | 2022-01-19 |
| Phase | Phase 1 |
What the finished NCT05027646 record still lists
NCT05027646 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Sancuso - Part 1 is the first listed.
NCT05027646 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05027646 about?
NCT05027646 is a clinical study titled "Study to Assess Bioequivalence and Adhesion Properties Between Two Granisetron Transdermal Patches.". 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 e...
What is the current status of trial NCT05027646?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2021-07-06. Estimated completion is 2022-01-19.
What conditions does trial NCT05027646 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05027646?
The interventions under investigation include: Sancuso - Part 1 (DRUG), Sancuso - Part 2 (DRUG).
Who is sponsoring clinical trial NCT05027646?
This trial is sponsored by Kyowa Kirin, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05027646 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05027646's enrollment target sits among peer trials
134 62nd of 283 higher than 221 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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