Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

Summary

The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy smokers.

Timeline

Start

2013-05

Primary completion

2013-06

Completion

2013-06

Outcome

Met primary endpoint

paper Both 2 and 4 mg doses of the new mint-flavored nicotine gum were bioequivalent to the dose-matched reference product as determined by the ratio of the geometric means and their 90% confidence intervals for Cmax and AUC0-t PMID 30027479 ↗

Publications

• Du D. A Single-Dose, Crossover-Design Bioequivalence Study Comparing Two Nicotine Gum Formulations in Healthy Subjects. Adv Ther. 2018 Aug;35(8):1169-1180. doi: 10.1007/s12325-018-0752-7. Epub 2018 Jul 19.

Drugs

Indications

No indication recorded.