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

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 7, 2015

Primary Completion Date

June 23, 2015

Study Completion Date

June 23, 2015

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)

Trial Locations (1)

CP 09360

Clinical Unit of Biodextra, S.A. de C.V., Mexico City

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Grünenthal Colombiana S.A.

INDUSTRY

lead

Grünenthal GmbH

INDUSTRY