A SINGLE-CENTER, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 4-WAY CROSSOVER STUDY TO EVALUATE THE PHARMACOKINETIC PROFILE OF FLURBIPROFEN FOLLOWING ADMINISTRATION OF 2 FLURBIPROFEN TRANSDERMAL FORMULATIONS COMPARED TO FROBEN® 50 MG AND YAKUBAN TAPE® IN HEALTHY SUBJECTS

A SINGLE-CENTER, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 4-WAY CROSSOVER STUDY TO EVALUATE THE PHARMACOKINETIC PROFILE OF FLURBIPROFEN FOLLOWING ADMINISTRATION OF 2 FLURBIPROFEN TRANSDERMAL FORMULATIONS COMPARED TO FROBEN® 50 MG AND YAKUBAN TAPE® IN HEALTHY SUBJECTS - Flurbiprofen transdermal patch relative bioavailability study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38802

Enrollment

Registered

2013-04-15

Start date

2013-04-24

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

On Day 1 of each period a 50 mg Froben® tablet will be administered with 240 ml of water in Period 1 after a fasting period (no food or drinks) of at least 10 hours. During 2 out of the 3 remaining

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: 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)