Bioequivalence study of valsartan 160 mg tablets
- Conditions
- ..
- Registration Number
- IRCT20130626013776N112
- Lead Sponsor
- Jaber Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 24
18-55 years of age
The subject is able and willing to provide signed informed consent
Willing to adhere to protocol requirements as evidenced by written informed consent
The subject has a stable residence and telephone
Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening
History of allergy or sensitivity to valsartan
History of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject of the study
Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction
Presence of gastrointestinal disease or history of malabsorption within the last year
History of a medical disorders occurring within the last year that required hospitalization or medication
Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing
Receipt of any drug as part of a research study within 30 days prior to the present study
Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum drug plasma concentration. Timepoint: At time zero and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations by high-performance liquid chromatography.;Area under plasma concentration-time curve. Timepoint: At time zero and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations by high-performance liquid chromatography.
- Secondary Outcome Measures
Name Time Method Time to reach the maximum plasma concentration. Timepoint: At time zero and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 h after drug administrationMethod of measurement?? ????? ???. Method of measurement: Time to reach the maximum plasma concentration is used.;Plasma half-life. Timepoint: From the terminal 16 hours of plasma concentration-time profile. Method of measurement: Blood sampling and drug analysis by high-performance liquid chromatography method.