Bioequivalence study.
Conditions
Interventions
Intervention 1: Intervention group 1: In this group, volunteers are given a single oral dose of Meloxicom 15 mg tablets, produced by Daana Co. (Domestic). After the washout period, the volunteers are
Sponsors
Daana pharmaceutical company
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: The weight limit for each volunteer is between 60 and 100 kg. All volunteers must be non-smokers. They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed.
Exclusion criteria
Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Meloxicam or any ingredients. Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg. Regular smoker who smokes more than ten cigarettes daily. Taking any medicine during two week before dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: At 0 (before dosing), 1? 2? 2.5? 3? 3.5? 4? 4.5? 5? 6? 8? 10? 12? 24? 48 and 72 hour after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS). | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC (Area Under the Concentration-Time Curve). Timepoint: During 2 months after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamed Hamishehkar
Tabriz University of Medical Sciences
Outcome results
None listed