A SINGLE-CENTER, SINGLE-DOSE, OPEN-LABEL, THREE-WAY-CROSSOVER STUDY TO EVALUATE THE PHARMACOKINETICS OF THE HP-3070 PATCH (ASENAPINE TRANSDERMAL DRUG DELIVERY SYSTEM) FOLLOWING 24-HOUR APPLICATION COMPARED TO SINGLE-DOSE SYCREST® 5 MG (ASENAPINE, SUBLINGUAL) IN HEALTHY ADULT MALE AND FEMALE SUBJECTS

Completed

• Conditions: bipolar disorder; Schizophrenia; 10026753

• Registration Number: NL-OMON36902
• Lead Sponsor: oven Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

Gezonde mannen en vrouwen
18-45 jaar
niet rokend
BMI 18-30 incl

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters 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>To evaluate the pharmacokinetics (PK) and relative bioavailability of asenapine<br /><br>following 24-hour (h) application of HP-3070 transdermal patches (containing<br /><br>3.6 or 4.8 mg asenapine maleate) in healthy adult male and female subjects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To compare the PK profile of asenapine following application of two different<br /><br>HP-3070 transdermal patches (3.6 and 4.8 mg of asenapine maleate) to that of a<br /><br>single sublingual (SL) dose of Sycrest® (5 mg asenapine tablet) in healthy<br /><br>adult male and female subjects<br /><br><br /><br>To assess skin irritation, discomfort, patch adhesion, adhesive residue, and<br /><br>difficulty of patch application to skin and removal from liner of HP-3070<br /><br>transdermal patch following 24 h application in healthy adult male and female<br /><br>subjects<br /><br><br /><br>To evaluate apparent dose and percentage asenapine maleate released from<br /><br>HP-3070 transdermal patch following 24 h application in healthy adult male and<br /><br>female subjects<br /><br><br /><br>To assess the safety and tolerability of HP-3070 transdermal patch following 24<br /><br>h application, and of a single SL dose of Sycrest® 5 mg in healthy adult male<br /><br>and female subjects</p><br>