Comparing Two Valsartan Tablets for Quality and Bioequivalence
Author Information
Author(s): Zaid Abdel Naser, Cortesi Rita, Qaddomi Aiman, Khammash Saed
Primary Institution: An-Najah National University
Hypothesis
The study aims to assess the quality of Valzan® tablet by comparing its pharmacokinetic parameters with Diovan® tablet.
Conclusion
The test tablets (Valzan®) are bioequivalent to the reference brand Diovan® based on pharmacokinetic profiles.
Supporting Evidence
- The pharmacokinetic parameters AUC0–48, AUC0–∞, Cmax, Tmax, Ke and T1/2 were determined for both tablets.
- The analysis of variance (ANOVA) did not show any significant difference between the two formulations.
- The relative bioavailability of Valzan® was found to be within the FDA specified bioequivalent limit (80–125%).
- Both medications were well tolerated at the administered dose by all subjects.
Takeaway
The study tested two types of valsartan tablets to see if they work the same way in the body, and they do!
Methodology
A randomized, two-way, crossover bioequivalence study was performed with 24 healthy male volunteers.
Limitations
The study only included healthy male volunteers aged 18-28, which may limit the generalizability of the results.
Participant Demographics
24 healthy male volunteers, aged 18-28 years, weighing between 67 and 83 kg.
Statistical Information
P-Value
p<0.05
Confidence Interval
90% confidence intervals fell within the acceptable range for bioequivalence.
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website