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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
Phase 1 trial testing Rotigotine transdermal patch in Healthy in 52 participants. Completed in 1 December 2008.
1 November 2008
Quick facts
| Lead sponsor | UCB Pharma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 52 |
| Start date | 1 October 2008 |
| Primary completion | 1 November 2008 |
| Estimated completion | 1 December 2008 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Rotigotine transdermal patch — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
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.
-
AUC(0-tz) of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application
The AUC(0-tz) is the area under the plasma concentration- time curve from zero up to the last analytically quantifiable concentration. -
Cmax of Unconjugated Rotigotine
Time frame: Pharmacokinetic samples were taken predose, after 1, 2, 3, 4, 6, 8, 12, 16, 24 (before patch removal), 25, 26, 28, 30, 32, 36, 40 and 48 hours after patch application.
The Cmax is the maximum plasma concentration.
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):
-
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
Verify or expand the search:
- PubMed search for NCT00881894
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00881894 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UCB Pharma
- Last refreshed: 17 October 2014
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing