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Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac

NCT03766984 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-12-11

No results posted yet for this study

Summary

The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Diclofenac sodium 25 mg

Diclofenac sodium 25 mg Tablets (Laboratorios Tecnandina S.A., Ecuador)

DRUG

Tramadol hydrochloride 25 mg

Tramadol hydrochloride 25 mg Tablets (Laboratorios Tecnandina S.A., Ecuador)

DRUG

Diclofenac sodium 25 mg/Tramadol hydrochloride 25 mg

Fixed-dose combination tablet containing diclofenac sodium 25 mg and tramadol hydrochloride 25 mg (Laboratorios Tecnandina S.A., Ecuador)

Sponsors & Collaborators

  • Grünenthal Colombiana S.A.

    collaborator INDUSTRY

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-06-07
Primary Completion
2015-06-23
Completion
2015-06-23

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 NCT03766984 on ClinicalTrials.gov