Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline

Phase 1 Completed 22 enrolled Oyster Point Pharma, Inc.

RandomizedCrossoverOpen-labelOther

Summary

To assess the relative bioavailability of varenicline administered intranasally at its highest intended clinical strength compared to varenicline administered orally at its highest oral tablet strength.

Timeline

Start: 2019-08-26
Primary completion: 2019-11-15
Completion: 2019-11-15

Publications

Nau J, Wyatt DJ, Rollema H, Crean CS. A Phase I, Open-label, Randomized, 2-Way Crossover Study to Evaluate the Relative Bioavailability of Intranasal and Oral Varenicline. Clin Ther. 2021 Sep;43(9):1595-1607. doi: 10.1016/j.clinthera.2021.07.020. Epub 2021 Aug 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Varenicline	Small molecule	0.12 mg	Intranasal
Subject	Varenicline	Small molecule	1 mg	Intranasal

Indications

No indication recorded.