A single-dose, crossover-design bioequivalence study comparing two nicotine gum formulations in healthy subjects
Advances in Therapy Jul 24, 2018
Du D - In this crossover study, researchers assessed new mint-flavored nicotine gum (2 and 4 mg strengths) for bioequivalence vs the original flavor sugar-free nicotine gum at corresponding dosages. Participants in the study received a single dose of all treatments, ie, 2 and 4 mg doses of test and reference gums, separated by 2–7 days of washout between treatments. Data reported that the new mint-flavored nicotine gum with modified taste and texture was bioequivalent to the original flavor sugar-free nicotine gum at both the 2 and 4 mg dosage strengths. The safety profiles of the test and reference gums were similar.
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