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

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 - HP -3070 Patch relative bioavailability study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36902

Enrollment

Registered

2012-09-13

Start date

2012-09-28

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bipolar disorder Schizophrenia

Interventions

period 1: sublingual tablet with asenapine dosed once on dag 1 period 2: transdermal patch application with 3.6 mg asenapine for 24 hours on day 1 period 3: transdermal patch application with 4.8 mg

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Secondary

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

Measure

Time frame

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

—

Primary

Measure	Time frame
To evaluate the pharmacokinetics (PK) and relative bioavailability of asenapine following 24-hour (h) application of HP-3070 transdermal patches (containing 3.6 or 4.8 mg asenapine maleate) in healthy adult male and female subjects	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)