title: A single and multiple dose study to investigate the pharmacokinetics of a prolonged release formulation of ropinirole in healthy Chinese subjects.
abstract: An open-label, single, and 7-day multiple dose study was conducted to investigate the pharmacokinetics, safety and tolerability of a prolonged release formulation of ropinirole 2 mg in healthy Chinese male (n = 12) and female (n = 12) subjects. After single doses, median tmax was 8 hours and mean t12 was 5.26 hours. After 7 days dosing, median tmax was 6 hours (t12 not determined). Systemic exposure, AUC and Cmax , following multiple and single dosing was similar (mean AUC(0-τ) (h ng/mL): 23.84 vs. AUC(0-∞) : 22.13; Cmax (ng/mL) 1.48 vs. 1.21, respectively). Systemic exposure was higher in females than males following single doses (mean AUC(0-24) (h ng/mL): 21.45 vs. 15.48; P = 0.009; Cmax (ng/mL): 1.40 vs. 0.99; P = 0.014, respectively), but similar at steady state (mean AUC(0-τ) (h ng/mL): 24.96 vs. 22.62; Cmax (ng/mL): 1.56 vs. 1.39, respectively). Estimated accumulation ratio was 1.29 (90% CI: 1.11, 1.51). Ropinirole did not display time-dependent pharmacokinetics (estimated steady state ratio: 1.09; 90% CI: 0.93, 1.27). The most common adverse events included dizziness and oral ulcer. In conclusion, Chinese subjects displayed predictable absorption, exposure and elimination following the prolonged release formulation of ropinirole 2 mg. The safety findings are consistent with the previously established safety profile for ropinirole.
authors.affiliation: Clinical Pharmacology Research Centre, Peking Union Medical College Hospital, Beijing, China.
authors.forename: Hongzhong
authors.initials: H
authors.lastname: Liu
authors.affiliation: Clinical Pharmacology Research Centre, Peking Union Medical College Hospital, Beijing, China.
authors.forename: Ji
authors.initials: J
authors.lastname: Jiang
authors.affiliation: Clinical Pharmacology Research Centre, Peking Union Medical College Hospital, Beijing, China.
authors.forename: Hongyun
authors.initials: H
authors.lastname: Wang
authors.affiliation: Clinical Pharmacology Research Centre, Peking Union Medical College Hospital, Beijing, China.
authors.forename: Xia
authors.initials: X
authors.lastname: Chen
authors.affiliation: Clinical Pharmacology Research Centre, Peking Union Medical College Hospital, Beijing, China.
authors.forename: Tao
authors.initials: T
authors.lastname: Liu
authors.affiliation: GlaxoSmithKline (China) R&D Company Limited, Shanghai, China.
authors.forename: Haijun
authors.initials: H
authors.lastname: Cao
authors.affiliation: GlaxoSmithKline, Uxbridge, United Kingdom.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Palmer
authors.affiliation: GlaxoSmithKline Emerging Markets & Asia Pacific, Shanghai, China.
authors.forename: Anita
authors.initials: A
authors.lastname: Gu
authors.affiliation: Clinical Pharmacology Research Centre, Peking Union Medical College Hospital, Beijing, China.
authors.forename: Pei
authors.initials: P
authors.lastname: Hu
keywords: Chinese; healthy subjects; pharmacokinetics; ropinirole