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Protocol Summaries: darotropium bromide

Protocol Summaries for darotropium bromide
GSK
Study ID		 Phase Title Status
112016 Phase 1 Phase I study of GSK233705 - A randomised, double blind, placebo-controlled, 2-parts study to investigate the safety, tolerability, and pharmacokinetics of single and repeat inhaled doses of GSK233705 from a novel dry powder device in healthy Japanese male subjects - Completed
AC2103473 Phase 1 A randomised, double blind, placebo-controlled, double dummy, 4-way cross-over, dose ascending study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 and tiotropium bromide (18µg) via DPI in COPD patients Completed
AC2105333 Phase 2 A Randomised, Double-Blind, Placebo-Controlled, Dose Ascending, 3 Period Crossover Study To Examine The Safety, Tolerability, Pharmacodynamics And Pharmacokinetics Of Repeat Inhaled Doses Of GSK233705B In COPD Subjects. Completed
AC2106213 Phase 1 A single-centre, open-label, sequential ascending cross over study to examine safety, tolerability, pharmacodynamics and pharmacokinetics of ascending single doses, nominally 10, 30, 70 and 110µg intravenous doses and a single 250µg oral dose of GSK233705 in healthy volunteers. Completed
AC2108378 Phase 2 A randomised, double-blind, placebo-controlled, dose ascending,2-cohort, parallel group study to examine the safety, tolerability, pharmacokinetics and pharmacodynamics of twice-daily inhaled doses of GSK233705B formulated with the excipient Magnesium Stearate in COPD subjects for 7-days. Completed
AC2108380 Phase 1 See Detailed Description Completed
AC2110664 Phase 2 Dose-Ranging Study for GSK233705B Delivered Once Daily in Subjects with COPD Completed

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