Comparison of Bioavailability of Dexketoprofen-Vit B vs Dexketoprofen, in Healthy Subjects, Under Fasting Conditions
Status:
Completed
Trial end date:
2019-12-02
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Treatments:
Dexketoprofen trometamol Folic Acid Vitamin B Complex