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

NCT03979989 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-06-10

No results posted yet for this study

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

DRUG

Tapentadol IR capsule

Tapentadol IR capsule containing 93 mg tapentadol hydrochloride.

DRUG

Omeprazole capsule

Omeprazole capsule containing 40 mg omeprazole.

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    collaborator INDUSTRY

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Study Director Grünenthal · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03979989 on ClinicalTrials.gov