drugset / Trial / NCT03075267
Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects
Timeline
- Start
- 2017-04-17
- Primary completion
- 2017-09-05
- Completion
- 2017-09-05
Publications
- Huang Y, Assam PN, Feng C, Su R, Dorinsky P, Gillen M. Ethnic pharmacokinetic comparison of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) between Asian and Western healthy subjects. Pulm Pharmacol Ther. 2020 Oct;64:101976. doi: 10.1016/j.pupt.2020.101976. Epub 2020 Nov 2.
- Chen Q, Hu C, Yu H, Shen K, Assam PN, Gillen M, Liu Y, Dorinsky P. Pharmacokinetics and Tolerability of Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate and Glycopyrronium/Formoterol Fumarate Dihydrate Metered Dose Inhalers in Healthy Chinese Adults: A Randomized, Double-blind, Parallel-group Study. Clin Ther. 2019 May;41(5):897-909.e1. doi: 10.1016/j.clinthera.2019.03.007. Epub 2019 Apr 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PT003 | Unknown | 14.4 ug | Inhaled |
| Subject | PT010 | Unknown | 160 ug | Inhaled |
| Subject | PT010 | Unknown | 320 ug | Inhaled |