analgesic and anti inflammation.
Conditions
Interventions
Intervention 1: Intervention group (Test): Celecoxib 200 mg capsules, produced by Daana Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. In th
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 Celecoxib 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), 0.5? 1? 1.5 ?2? 2.5? 3? 3.5? 4? 6? 8 ? 12? 24 and 48 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