A single-center, open-label, randomized, 3-way crossover study to evaluate the pharmacokinetic profile and tolerability of Flurbiprofen following administration of two Flurbiprofen transdermal formulations compared to Yakuban Tape® in healthy subjects

A single-center, open-label, randomized, 3-way crossover study to evaluate the pharmacokinetic profile and tolerability of Flurbiprofen following administration of two Flurbiprofen transdermal formulations compared to Yakuban Tape® in healthy subjects - Flurbiprofen transdermal patch pharmacokinetics study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40944

Enrollment

Registered

2014-04-07

Start date

2014-05-08

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

ontstekingen, reumatoïde artritis, spieraandoeningen Inflammation

Interventions

During the study, the flurbiprofen patches will be applied to the lower back for 24 hours (FTS-A2 and FTS-B2) or 2 times 12 hours (Yakuban Tape®). Study personnel will apply the patches and will pre

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy subjects 18-65 years, inclusive BMI: 18.0-30.0 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 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
To evaluate the PK profile of flurbiprofen following the administration of two different formulations of FTS (35 mg flurbiprofen / 70 cm2).	—

Secondary

Measure	Time frame
To compare the PK profile of flurbiprofen following a single 24-hour application of FTS (35 mg flurbiprofen / 70 cm2) to that following a twice-a-day application of Yakuban Tape® (20 mg flurbiprofen / 70 cm2). To assess the adhesion, discomfort, irritation and adhesive residue of the transdermal systems. To assess the safety and tolerability of FTS and Yakuban Tape®.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)