drugset / Trial / NCT03951987

Investigation How CG5503 is Taken up and Excreted From the Body After 2 Minutes Intravenous Infusion With and Without Oral Co-administration of Charcoal

NCT03951987

Phase 1 Completed 14 enrolled Grünenthal GmbH
RandomizedCrossoverOpen-labelTreatment

Summary

This was a Phase I study in 12 healthy male participants to compare the pharmacokinetic properties of CG5503 (how it is taken up and excreted from the body) after 2 minutes intravenous (i.v.) infusion with and without oral co-administration of charcoal to investigate a potential gastrointestinal secretion of CG5503. During the course of the study each participant received two infusions of 40 mg CG5503 without (treatment A) and with (treatment B) oral co-administration of charcoal. In treatment B, eight doses of 5 grams charcoal powder were co-administered orally at defined time points. The wash out phases were to be at least 4 to 14 days between the treatment periods.

Timeline

Start
2004-02
Primary completion
2004-04
Completion
2004-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Activated Charcoal Other / unclassified 5 g Oral
Subject Tapentadol Small molecule 40 mg Intravenous

Indications

No indication recorded.