A SINGLE-CENTER, OPEN-LABEL, ONE-SEQUENCE, THREE-PERIOD CROSSOVER STUDY TO EVALUATE THE PHARMACOKINETICS OF HP-3040 PATCHES (TOLTERODINE TRANSDERMAL DRUG DELIVERY SYSTEM) FOLLOWING 168-HR APPLICATION COMPARED TO SINGLE-DOSE DETROL® LA 2 MG (TOLTERODINE TARTRATE EXTENDED RELEASE CAPSULE) IN HEALTHY ADULT MALE SUBJECTS

Completed

• Conditions: urine incontinentie; involuntary leakage of urine; loss of bladder control

• Registration Number: NL-OMON37479
• 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: 12

Inclusion Criteria

healthy male subjects
18-45 yrs, inclusive
BMI: 18.0-30.0 kg/m2, inclusive
non-smoking or a light smoker (less than 5 cigarettes per day for minimal 6 months)
light skin color

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>Pharmacokinetics: tolterodine, 5-hydroxymethyl tolterodine and the combined<br /><br>active moiety (tolterodine + 5 hydroxymethyl tolterodine) serum concentrations<br /><br>and PK parameters<br /><br>Dermal evaluations: presence and severity of skin irritation and discomfort,<br /><br>patch adhesion, amount of adhesive residue at application site<br /><br>Other evaluations: difficulty of patch removal from the liner, residual drug<br /><br>analysis<br /><br>Safety: AEs, vital signs, ECG, clinical laboratory assessments, physical<br /><br>examination</p><br>

Secondary Outcome Measures

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