Drug-drug Interaction Study to Evaluate the Effect of Omeprazole on CG5503 (Tapentadol)

Phase 1 Completed 32 enrolled Grünenthal GmbH Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · collab

RandomizedCrossoverOpen-labelTreatment

Summary

This was a single center, open-label, two-way crossover, drug-drug-interaction study to determine the effect of multiple dosing of omeprazole on 4 consecutive days on the pharmacokinetics of a single dose of an immediate-release capsule of CG5503 (tapentadol) in healthy participants.

Timeline

Start: 2005-09-28
Primary completion: 2005-11-16
Completion: 2005-11-16

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omeprazole	Other / unclassified	40 mg	Oral
Subject	Tapentadol	Small molecule	93 mg	Oral

Indications

No indication recorded.