drugset
drugset / Trial / NCT02494830

Single Dose Administration of Ketamine 10, 20, 40 and 80 mg and 5 mg Solution for Infusion in 15 Healthy Subjects

NCT02494830 ↗

Phase 1 Completed 15 enrolled University Medicine Greifswald
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is designed for descriptive pharmacokinetic characterization of ketamine and norketamine in serum, urine and feces after oral single dose administration of a new developed prolonged release tablet formulation containing 10, 20, 40 and 80 mg ketamine under fasting conditions and for descriptive pharmacokinetic characterization of ketamine and norketamine in serum, urine and feces after intravenous single dose administration of 5 mg ketamine solution for infusion within 30 min

Timeline

Start
2014-08
Primary completion
2014-09
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 5 mg Intravenous
Subject Ketamine Small molecule 10 mg Intravenous
Subject Ketamine Small molecule 20 mg Intravenous
Subject Ketamine Small molecule 40 mg Intravenous
Subject Ketamine Small molecule 80 mg Intravenous

Indications

No indication recorded.