Bioequivalence and Adhesion of a Rotigotine Patch in Healthy Subjects
brief summary
This study was intended to demonstrate bioequivalence of the Amarin's Rotigotine patch respect to Neupro, (RLD), as well as non-inferiority in adhesion, when tested at a dose of 2 mg/24h in healthy subjects of both sexes. Local and systemic adverse events were also monitored and reported. Worn patches were recovered and analysed to compare residual drug.
detailed description
Objectives:
* To evaluate the bioequivalence and the non-inferiority in the adhesion of Rotigotina B7 TDS (2 mg/24h) (Rotigotine Transdermal Patch 2 mg/24 hours) respect to 'NEUPRO®' (Rotigotine) 2 mg/24 hours Transdermal Patch in healthy, adult human participants. * To compare the residual drug content, cold flow properties and to monitor the safety and tolerability of the participants.
Methodology:
This evaluator-blinded, randomized, two-period, two-treatment, four-sequence, crossover, balanced, single dose bioequivalence and adhesion study in healthy adult human participants was conducted to evaluate the bioequivalence and the non-inferiority in the adhesion of test formulation respect to reference formulation. The study was conducted with 36 (32 Male + 04 Female) participants and 35 participants (31 Male + 04 Female) completed the study in accordance with protocol. A single patch of either the test product Rotigotina B7 TDS (2mg/24h) (Rotigotine Transdermal Patch 2 mg/24 hours) (T) or the reference product (R). Neupro® 2 mg/24 h Transdermal Patch Rotigotin (e) was applied for 24 hours on the healthy skin (that was clean, dry, hairless and free of redness, irritation, burns or cuts) on left or right side of upper arm according to the randomization schedule of each participant in each study period (on Day 0 for Period 1 and Day 3 for Period 2) at ambient temperature.
Blood samples were collected at pre-dose (0.0 hour) and at 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, 13.0, 14.0, 15.0, 16.0, 17.0, 18.0, 19.0, 20.0, 22.0, 24.0 (prior to removal), 26.0, 28.0, 32.0, 36.0, 42.0 and 48.0 hours post dose in each period. The plasma samples were shipped to the Bioanalytical facility for analysis.
Statistical analysis was performed on pharmacokinetic parameters to compare and evaluate the bioequivalence and statistical analysis was performed on adhesion score data to evaluate the non-inferiority in the adhesion of test formulation to the reference formulation. Bioequivalence was determined by a statistical comparison of Cmax, AUCt and AUCi for the test and reference products for Rotigotine. To demonstrate adhesiveness, the 90% confidence interval of mean adherence for the test product at the end of the dosing interval was to be lie above 90%.
official title
Single Dose Bioequivalence and Adhesion Study of Rotigotina B7 TDS (2 mg/24h) (Rotigotine Transdermal Patch 2 mg/24 Hours) and 'NEUPRO®' (Rotigotine) 2 mg/24 Hours Transdermal Patch in Healthy Adult Human Participants.