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Bioequivalency of three tableted gallopamil products
Bollettino Chimico Farmaceutico
|May 1, 1989
Summary
This study found no significant differences in the bioavailability of gallopamil tablets A, B, and C. However, Product B showed a longer absorption time, potentially offering advantages in multiple dosing scenarios.
Area of Science:
- Pharmacokinetics
- Drug bioavailability
- Clinical pharmacology
Background:
- Gallopamil is a medication used for cardiovascular conditions.
- Understanding the relative bioavailability of different formulations is crucial for therapeutic efficacy.
- Existing gallopamil formulations require comparative analysis.
Purpose of the Study:
- To evaluate and compare the relative bioavailability of three gallopamil tablet formulations: Product A (Galcan 25 mg), Product B (Galcan 50 mg), and Product C (Procorum 50 mg).
Main Methods:
- A three-way crossover study involving 12 healthy male volunteers.
- Single tablet administration after an overnight fast.
- Blood sample collection over 12 hours to determine plasma concentration-time profiles.
Main Results:
- No statistically significant differences in mean area under the plasma concentration-time curves (AUC) were observed among the three products after dose correction.
- Relative bioavailability of Product A and Product B compared to Product C was 96.3% and 103.1%, respectively.
- Significant differences in Tmax (time to maximum concentration) were found: Product C (1.0 hr) vs. Product A (2.1 hr) and Product B (2.4 hr).
Conclusions:
- All three gallopamil formulations exhibit comparable overall bioavailability.
- Product B demonstrates a longer absorption phase compared to Product C, which may reduce peak-to-trough fluctuations in plasma concentrations during multiple dosing.
- Product B may offer an advantage for patients requiring consistent therapeutic levels over time.