A single-center, randomized, open-label, 3 way crossover study to evaluate the single and multiple dose pharmacokinetic profile of HP-5000 compared to PENNSAID® 2% in healthy volunteers

A single-center, randomized, open-label, 3 way crossover study to evaluate the single and multiple dose pharmacokinetic profile of HP-5000 compared to PENNSAID® 2% in healthy volunteers - HP-5000 / PENNSAID 2% 3 way crossover study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42086

Enrollment

Registered

2014-10-20

Start date

2014-11-03

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

onstekingen Inflammation

Interventions

During this study the volunteer will receive in random order 3 treatments in 3 periods. The volunteer will thus receive each treatment once and will receive only 1 treatment in each period. The orde

on Day 1 and from Day 3 up to and including Day 16 once daily (every 24 hours) a new patch will be applied to the upper part of the back. Treatment B: HP-5000-DRS400 transdermal patches, containing 1

on Day 1 and from Day 3 up to and including Day 16 once daily (every 24 hours) a new patch will be applied to the upper part of the back. Treatment C: PENNSAID® 2% solution, containing 40 mg diclofen

once on Day 1 and twice daily from Day 3 up to and including Day 16, 2 mL will be applied to an area of 140 cm2 on the upper part of the back In every period, Day 1 is the day of first study medicat

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy volunteers 18 - 65 years, inclusive 18 - 30 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 30 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
The primary objective is to evaluate the single and multiple dose PK of Diclofenac and dimethyl sulfoxide (DMSO), obtained from two formulations of HP-5000 compared to PENNSAID® 2%	—

Secondary

Measure	Time frame
* To evaluate irritation, adhesion, discomfort, pain and adhesive residue of two formulations of HP-5000 * To evaluate the safety and tolerability of two formulations of HP-5000	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)