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View article: A first-in-human study in healthy subjects of the safety and pharmacokinetics of CNM-Au8, a suspension of catalytically active gold nanocrystals with remyelinating and neuroprotective properties
A first-in-human study in healthy subjects of the safety and pharmacokinetics of CNM-Au8, a suspension of catalytically active gold nanocrystals with remyelinating and neuroprotective properties Open
CNM-Au8 is a suspension of catalytically-active gold nanocrystals, developed to treat neurodegenerative disease. A first-in-human single- and multiple-ascending dose study was performed to assess safety and pharmacokinetics of CNM-Au8. The…
View article: A phase 1, open-label, single-arm study evaluating the ocular safety of OTX-101 and systemic absorption of cyclosporine in healthy human volunteers
A phase 1, open-label, single-arm study evaluating the ocular safety of OTX-101 and systemic absorption of cyclosporine in healthy human volunteers Open
Paul M Karpecki,1,2 Sidney L Weiss,3 William G Kramer,4 Patrick O’Connor,5 David Evans,6 Josh Johnston,7 April L Jasper,8 Angela Justice,9 Abayomi B Ogundele,9 Doug Devries10 1Kentucky Eye Institute, Lexington, KY, USA; 2Gaddie Eye Centers…
View article: A Phase I study evaluating the effect of age and weight on the pharmacokinetics of an injectable formulation of diclofenac solubilized with hydroxypropyl-β-cyclodextrin
A Phase I study evaluating the effect of age and weight on the pharmacokinetics of an injectable formulation of diclofenac solubilized with hydroxypropyl-β-cyclodextrin Open
Ronald Goldwater,1 William G Kramer,2 Douglas A Hamilton,3,4 Eric Lang,4,5 Jianyuan Wang,4 Donna E Madden,4 Peter G Lacouture,6,7 Atulkumar Ramaiya,8 Daniel B Carr4,9 1PAREXEL International, Baltimore, MD, 2Kramer Consulting, LLC, North Po…
View article: Bioavailability study of dronabinol oral solution versus dronabinol capsules in healthy volunteers
Bioavailability study of dronabinol oral solution versus dronabinol capsules in healthy volunteers Open
Neha Parikh,1 William G Kramer,2 Varun Khurana,1 Christina Cognata Smith,1 Santosh Vetticaden,1 1INSYS Therapeutics, Inc., Chandler, AZ, USA; 2Kramer Consulting LLC, North Potomac, MD, USA Background: Dronabinol, a pharmaceutical Δ-9-tetra…