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Administration of Tramadol and Ketorolac Separately and Simultaneously to Assess a Potential Pharmacokinetic Interaction

NCT03767036 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-12-11

No results posted yet for this study

Summary

Tramadol (Tradol) and ketorolac (Dolac) are marketed products to treat acute pain. This study was performed to determine if both medications can be given to a patient simultaneously without a change of the products' bioavailability.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Tramadol hydrochloride 25 mg capsule

Capsule with tramadol hydrochloride 25 mg; Product of Grünenthal de Mexico S.A. de C.V.

DRUG

Ketorolac Tromethamine 10 mg tablet

Tablet with ketorolac tromethamine 10 mg; Product of Siegfried Rhein, S.A. de C.V., Mexico

Sponsors & Collaborators

  • Grünenthal Colombiana S.A.

    collaborator INDUSTRY

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2017-06-05
Primary Completion
2017-06-28
Completion
2017-06-30

Countries

  • Mexico

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 NCT03767036 on ClinicalTrials.gov