A SINGLE-CENTER, SINGLE-DOSE, OPEN-LABEL, FOUR-WAY-CROSSOVER STUDY TO EVALUATE THE PHARMACOKINETIC PROFILE OF THE HP-5000 PATCH (DICLOFENAC SODIUM TRANSDERMAL DRUG DELIVERY SYSTEM) FOLLOWING 24-HOUR APPLICATION COMPARED TO FLECTOR® AND VOLTAREN® 100 MG IN HEALTHY ADULT MALE AND FEMALE SUBJECTS UNDER FASTING CONDITIONS

A SINGLE-CENTER, SINGLE-DOSE, OPEN-LABEL, FOUR-WAY-CROSSOVER STUDY TO EVALUATE THE PHARMACOKINETIC PROFILE OF THE HP-5000 PATCH (DICLOFENAC SODIUM TRANSDERMAL DRUG DELIVERY SYSTEM) FOLLOWING 24-HOUR APPLICATION COMPARED TO FLECTOR® AND VOLTAREN® 100 MG IN HEALTHY ADULT MALE AND FEMALE SUBJECTS UNDER FASTING CONDITIONS - HP-5000 transdermal patch study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37576

Enrollment

Registered

2012-04-16

Start date

2012-05-02

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

ontstekingen inflammation

Interventions

Treatment A: one Voltaren® XR oral tablet (containing 100 mg diclofenac sodium) under fasting conditions Treatment B: one HP-5000-75A transdermal patch applied vertically on the back for 24 hours un

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male and female subjects 18-40 yrs, inclusive BMI: 18.0-30.0 kg/m2, inclusive non-smoking 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: diclofenac plasma concentrations and PK parameters Dermal evaluations, patch adhesion, amount of adhesive residue application site, difficulty of patch removal, 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)