Bioequivalence study of Pantoprazole 40 mg tablet
Not Applicable
Not yet recruiting
- Conditions
- This study is performed on healthy volunteers..
- Registration Number
- IRCT20200623047902N33
- Lead Sponsor
- Ronak Pharm company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-28)
Informed consent
Age (18-55 years old)
Exclusion Criteria
Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcohol and drug addiction
History of allergy to Pantoprazole
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The plasma concentration of the drug. Timepoint: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10 and 12 h after drug administration. Method of measurement: Liquid Chromatography Mass-Mass.
- Secondary Outcome Measures
Name Time Method Time to reach maximum plasma concentration. Timepoint: After intervention. Method of measurement: The time to reach the maximum drug concentration in plasma is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of Pantoprazole's H+/K+ ATPase inhibition in healthy volunteers?
How does Ronak Pharm's Pantoprazole 40 mg compare to originator brands in pharmacokinetic parameters like AUC and Cmax?
Which biomarkers correlate with gastric acid suppression efficacy in Pantoprazole bioequivalence trials?
What adverse events are associated with Pantoprazole 40 mg in fasted-state clinical studies?
How does Pantoprazole's bioavailability in IRCT20200623047902N33 compare to other proton pump inhibitors in GERD treatment?