Study of absorption and elimination rate of Esomeprazole 10 mg sachet in comparison with standard sachet of Esomeprazole (Nexium®).
Not Applicable
- Conditions
- In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Esomeprazole 10 mg of test and reference in healthy volunteers..
- Registration Number
- IRCT20200407046981N12
- Lead Sponsor
- ???? ???????? ????? ????? ????????
- Brief Summary
Not available
- Detailed Description
Not available
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 Esomeprazole 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, 5, 6, 7, 8, 10, 12 and 24 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.