NCT03979989

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

An Open-Label, Two-Way Crossover, Drug-Interaction Study to Determine the Effect of Omeprazole on the Pharmacokinetics of an Immediate-Release Capsule of CG5503 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetic

Interventions

Type	Name	Description
DRUG	Tapentadol IR capsule	Tapentadol IR capsule containing 93 mg tapentadol hydrochloride.
DRUG	Omeprazole capsule	Omeprazole capsule containing 40 mg omeprazole.

Timeline

• Start date: 2005-09-28
• Primary completion: 2005-11-16
• Completion: 2005-11-16
• First posted: 2019-06-10
• Last updated: 2019-06-10

Locations

1 site across 1 country: Belgium