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Phentolamine bioequivalence study.

L F G Silva¹, M O Moraes, G S M Santana

¹Urology, Clinical Pharmacology Unit (UNIFAC), Federal University of Ceara, Brazil. unifac@roadnet.com.br

International Journal of Clinical Pharmacology and Therapeutics

|February 6, 2004

Summary

This study found Regitine 40 mg tablets bioequivalent to Vasomax. Both formulations demonstrated comparable phentolamine absorption rates and extents in healthy male volunteers.

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Area of Science:

Pharmacokinetics
Bioequivalence Studies
Analytical Chemistry

Background:

Phentolamine is a medication used for various conditions.
Assessing bioequivalence is crucial for generic drug approval.
Two phentolamine 40 mg tablet formulations were compared.

Purpose of the Study:

To determine the bioequivalence of Regitine (test) and Vasomax (reference) phentolamine 40 mg tablet formulations.
To compare the rate and extent of absorption of the two phentolamine formulations.

Main Methods:

A randomized, 2-period crossover study in 36 healthy male volunteers.
Single 40 mg oral dose of each formulation administered.
Plasma phentolamine concentrations measured using LC-MS-MS over 720 minutes postdose.

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Pharmacokinetic parameters including Cmax and AUC calculated.

Main Results:

The Cmax geometric mean ratio of Regitine to Vasomax was 108.29% (90% CI: 98.58-118.96).
The AUC(0-720 min) geometric mean ratio of Regitine to Vasomax was 102.33% (90% CI: 97.21-107.72).
Both formulations were well-tolerated with no serious adverse reactions.

Conclusions:

The 90% confidence intervals for both Cmax and AUC ratios fell within the FDA-recommended 80-125% range.
Regitine 40 mg tablets are bioequivalent to Vasomax 40 mg tablets.
The study supports the interchangeability of these two phentolamine formulations.