drugset / Trial / NCT02329561
PK PD of the Enantiomers of Tramadol and O-desmethyltramadol in Elderly and Young Subjects
Phase 1
Completed
35 enrolled
University of Montreal
Labopharm Inc. · collabMDS Pharma Services · collab
RandomizedCrossoverQuadruple-blindBasic science
Summary
This study evaluates the pharmacokinetics and pharmacodynamics of the enantiomers of tramadol and O-desmethyltramadol (ODM) in generally healthy young and elderly adults. Using a randomised, double-blind, crossover design, participants were administered a single 200mg tramadol extended-release tablet and placebo.
Timeline
- Start
- 2007-01
- Primary completion
- 2007-02
- Completion
- 2007-02
Publications
- Robertson SS, Mouksassi MS, Varin F. Population Pharmacokinetic/Pharmacodynamic Modeling of O-Desmethyltramadol in Young and Elderly Healthy Volunteers. Drugs Aging. 2019 Aug;36(8):747-758. doi: 10.1007/s40266-019-00681-w.
- Skinner-Robertson S, Fradette C, Bouchard S, Mouksassi MS, Varin F. Pharmacokinetics of Tramadol and O-Desmethyltramadol Enantiomers Following Administration of Extended-Release Tablets to Elderly and Young Subjects. Drugs Aging. 2015 Dec;32(12):1029-43. doi: 10.1007/s40266-015-0315-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tramadol | Other / unclassified | 200 mg | — |
Indications
No indication recorded.