Study of absorption and elimination rate of Celecoxib 200 mg capsules in comparison with standard capsules of Celecoxib (Celebrex®).

Not Applicable

• Conditions: analgesic and anti inflammation.

• Registration Number: IRCT20200407046981N11
• Lead Sponsor: Daana pharmaceutical company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 24

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.