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NCT00881894

Single-site, Open-label, Randomized, Cross-over Trial to Evaluate the Bioequivalence of Single Dose Rotigotine Transdermal Patch (4.5mg/10cm^2) From 2 Different Manufacturing Processes

Completed Phase 1 Results posted Last updated 17 October 2014
What this trial tests

Phase 1 trial testing Rotigotine transdermal patch in Healthy in 52 participants. Completed in 1 December 2008.

Timeline
1 October 2008
Primary endpoint
1 November 2008
1 December 2008

Quick facts

Lead sponsorUCB Pharma
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposebasic science
Enrollment52
Start date1 October 2008
Primary completion1 November 2008
Estimated completion1 December 2008
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

UCB Pharma — full company profile →

Who can join

Adults 18 to 55, male only, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing processes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Comparison of the bioavailability and adhesiveness of different rotigotine transdermal patch formulations.
    Elshoff JP, Timmermann L, Schmid M, Arth C, et al · · 2013 · cited 8× · PMID 24006953 · DOI 10.1185/03007995.2013.841666

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Other recruiting trials for Healthy

Currently open trials in the same condition.

Other UCB Pharma trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00881894.

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