Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

Phase 1 Completed 84 enrolled GlaxoSmithKline

RandomizedCrossoverOpen-labelTreatment

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

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

Evaluation	Drug	Modality	Dose	Route
Subject	Nicotine	Unknown	2 mg	Other
Subject	Nicotine	Unknown	4 mg	Other

Indications

No indication recorded.