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Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen, in Healthy Subjects, Under Fasting Conditions

NCT05027126 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-09-05

No results posted yet for this study

Summary

Bioavailability comparison study with a cross-over desing, 2x2, open, prospective and longitudinal, at a single dose with two treatments, two periods, two sequences with an elimination (washout) period of 7 days and a number of 36 healthy subjects, of both genders, under fasting conditions, of reference tablets of Dexketoprofen 25 mg (Stadium®), elaborated by Grimann, S.A. de C.V., and capsule test drug with Dexketoprofen 25 mg- Vitamin B complex elaborated by Laboratorios Silanes S.A. de C.V.

Conditions

  • Healthy

Interventions

DRUG

Dexketoprofen 25 MG

Pharmaceutical Form: Tablets Dosage: 25 mg Adminstration way: Oral

DRUG

Fixed dose Dexketoprofen-Vitamin B Complex

Pharmaceutical Form: capsule Dosage: 25 mg of Dexketoprofen + Cyanocobalamin 500 µg, Thiamine 100 mg, Pyridoxine 50 mg. Administration way: oral

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Lourdes Garza Ocaña, M.D · Department of Pharmacology and Toxicology of the Faculty of Medicine of the U.A.N.L

  • Eduardo J Tamez de la O, M.D · Department of Pharmacology and Toxicology of the Faculty of Medicine of the U.A.N.L

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
2019-02-28
Primary Completion
2019-11-15
Completion
2019-12-02

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 NCT05027126 on ClinicalTrials.gov