An open-label, individual study groups, fixed sequence, four-period crossover study comparing three proportionate sizes of HP 3020 patch applied for 24 hours with intravenous palonosetron injection (ALOXI®) and a one-period study with one size of HP-3020 patch applied for 168 hours, to investigate the pharmacokinetics, tolerability and safety of HP-3020 patches in healthy male subjects

Completed

• Conditions: chemotherapy induced nausea; chemotherapy induced vomiting; 10027656

• Registration Number: NL-OMON34113
• Lead Sponsor: Hisamitsu Pharmaceutical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

- age 18- 55 year
- BMI 18.0 - 29.9
- caucasian

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study or in case of donating more than 1 liter of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Pharmacokinetics<br /><br>- Safety</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>