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

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 - HP-3040 transdermal patch study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37479

Enrollment

Registered

2012-02-10

Start date

2012-02-16

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

urine incontinentie involuntary leakage of urine loss of bladder control

Interventions

Treatment A: one Detrol® LA, 2 mg oral capsule (2 mg tolterodine tartrate) administered under fasting conditions Treatment B: one HP-3040-75 transdermal patch (containing 75 mg tolterodine tartrate)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Primary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)