NCT05027126

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

Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen (Stadium®), Dose 25 mg in Healthy Subjects, of Both Genders, Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study was designed to recruit 36 healthy subjects considering a 2x2 design, where each subject received both treatments and was its own control. The time was adjusted considering the half-life of the drugs to be evaluated. Healthy subjects of both genders were selected since no relevant pharmacokinetic differences related to gender had been reported for the study drug. The aim of the study was to comparatively evaluate, in the same individuals the plasma concentrations of Dexketoprofen 25 mg from two pharmaceutical formulations; 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

Type	Name	Description
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

Timeline

• Start date: 2019-02-28
• Primary completion: 2019-11-15
• Completion: 2019-12-02
• First posted: 2021-08-30
• Last updated: 2021-09-05

Locations

1 site across 1 country: Mexico