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Active Ingredient: Verapamil hydrochloride Dosage Form; Route: Recommended Studies: Type of study: Fasting Design: Single-dose, two-way, crossover in-vivo Strength: 120 mg Subjects: Normal healthy males and females, general population Additional Comments: Females should not be pregnant, and verapamil while pregnant verapamil vestibular migraine verapamil quinidine interaction verapamil qt if applicable, should practice abstention or contraception during the study .
Type of study: Fed Design: Single-dose, two-way, crossover in-vivo Strength: 120 mg Subjects: Normal healthy males and females, general population Additional comments: Please see comment above Analytes to measure: Verapamil and its active metabolite, norverapamil in plasma Please submit the metabolite verapamil data as supportive evidence of comparable therapeutic outcome .
For the metabolite, the following data should be submitted: verapamil individual and mean concentrations, individual and mean pharmacokinetic parameters, and geometric means and ratios of means for AUC and Cmax .
Bioequivalence based on (90% verapamil CI): Verapamil Waiver request of in-vivo testing: 40 mg and 80 mg based on (i) acceptable bioequivalence studies on the 120 mg strength, (ii) acceptable dissolution testing across all strengths, and (iii) proportional similarity in the formulations across all strengths .
Dissolution test method verapamil and sampling times: The dissolution information for this drug product can be found on the FDA-Recommended Dissolution Methods web site, available to the public at the following location: http://www .
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