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pK of a Novel 200 mg Ibuprofen Medicated Plaster

NCT03694587 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-04-16

No results posted yet for this study

Summary

This is a Phase I study of the pharmacokinetics of a novel 200 mg Ibuprofen Medicated Plaster. The study will be conducted as a monocentric, open, randomised, single and multiple-dose, two-period, crossover trial in healthy volunteers. A total of 16 healthy volunteers will be randomised.

A wash-out period of 3 days is planned between the two periods. Each of the volunteers will be randomly assigned to one of 2 possible administration sequences.

Conditions

  • Healthy

Interventions

DRUG

Ibuprofen 200 mg TEPI Medicated Plaster

Ibuprofen 200mg TEPI medicated plaster applied to the upper back daily for 24 hours for 5 days

DRUG

Aktren® 200 mg überzogene Tabletten (Ibuprofen)

one dose of Aktren® 200 mg überzogene Tabletten (Ibuprofen tablet)

Sponsors & Collaborators

  • Cooperative Clinical Drug Research and Development AG (CCDRD AG)

    collaborator OTHER

  • Medherant Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-25
Primary Completion
2018-10-18
Completion
2018-10-18

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03694587 on ClinicalTrials.gov