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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Activated Charcoal | Other / unclassified | 5 g | Oral |
| Subject | Tapentadol | Small molecule | 40 mg | Intravenous |
Indications
No indication recorded.