Single-site, Open-label, Randomized, Cross-over Study in Healthy Japanese Subjects to Evaluate the Bioequivalence of Single Dose Rotigotine Transdermal Patch (2 mg/24 h) Comparing 2 Different Formulations

NCT01565018 Phase 1 COMPLETED

To investigate and compare the drug amount delivered to the body after each single administration of Rotigotine patch with 2 different formulations in healthy Japanese subjects.

Details

Lead sponsor	UCB Pharma
Phase	Phase 1
Status	COMPLETED
Enrolment	55
Start date	2012-03
Completion	2012-07

Conditions

• Healthy Volunteers

Interventions

• Rotigotine PR 2.1.4
• Rotigotine PR 2.2.1

Primary outcomes

• Maximum plasma concentration of unconjugated Rotigotine (Cmax) — Pharmacokinetic (PK) samples will be taken predose, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h and 48 h after Rotigotine administration
  The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.
• Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration of unconjugated Rotigotine (AUC 0-t) — Pharmacokinetic (PK) samples will be taken predose, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h (before patch removal in the morning of Day 2), 25 h, 26 h, 28 h, 30 h, 32 h, 36 h, 40 h and 48 h after Rotigotine administration

Countries

Germany