drugset / Trial / NCT04027972
Pharmacokinetics of Neostigmine and Glycopyrrolate
NaSingle-groupOpen-labelTreatment
Summary
A group of 6 able-bodied healthy volunteers will receive Neostigmine (NEO) and Glycopyrrolate (GLY) intravenously and via 2 methods of Iontophoresis (ION): one-patch and two-patch administration, with subsequent blood draws over 1 hour in order to measure the pharmacokinetic behavior of the drugs in-vivo.
Timeline
- Start
- 2020-03-09
- Primary completion
- 2022-12-20
- Completion
- 2022-12-20
Publications
- Background Korsten MA, Lyons BL, Radulovic M, Cummings TM, Sikka G, Singh K, Hobson JC, Sabiev A, Spungen AM, Bauman WA. Delivery of neostigmine and glycopyrrolate by iontophoresis: a nonrandomized study in individuals with spinal cord injury. Spinal Cord. 2018 Mar;56(3):212-217. doi: 10.1038/s41393-017-0018-2. Epub 2017 Nov 8.
- Background Korsten MA, Rosman AS, Ng A, Cavusoglu E, Spungen AM, Radulovic M, Wecht J, Bauman WA. Infusion of neostigmine-glycopyrrolate for bowel evacuation in persons with spinal cord injury. Am J Gastroenterol. 2005 Jul;100(7):1560-5. doi: 10.1111/j.1572-0241.2005.41587.x.
- Background Chang JY, Locke GR 3rd, McNally MA, Halder SL, Schleck CD, Zinsmeister AR, Talley NJ. Impact of functional gastrointestinal disorders on survival in the community. Am J Gastroenterol. 2010 Apr;105(4):822-32. doi: 10.1038/ajg.2010.40. Epub 2010 Feb 16.
- Background Sabiev A, Korsten MA, Bauman WA (2021) A Comparison among Three Skin Preparations for the Transdermal Delivery of Vitamin B12 by Iontophoresis: A Novel Approach to Determine Systemic Absorption. J Pharm Drug Deliv Res 10:3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glycopyrrolate | Small molecule | 0.004 mg/kg | Intravenous |
| Subject | Glycopyrrolate | Small molecule | 0.014 mg/kg | Intravenous |
| Subject | Neostigmine | Other / unclassified | 0.02 mg/kg | Intravenous |
| Subject | Neostigmine | Other / unclassified | 0.07 mg/kg | Intravenous |