NCT02839135

A Comparative Bioavailability and Adhesion Performance Study, Comparing a New Scopolamine Transdermal Delivery System Formulation to the Currently Established Reference Transdermal Delivery System in Healthy Adult Participants.

A Randomized, Single-center, Crossover, Comparative Bioavailability and Adhesion Performance Study, Comparing Single Administrations of a New Scopolamine Transdermal Delivery System Formulation to the Currently Established Reference Transdermal Delivery System in Healthy Adult Participants.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

In this comparative bioavailability and in vivo skin adhesion study, the impact of minor changes in qualitative composition of polyiso-Butylenes (PIB) from a different supplier and change of the manufacturing line of the micro porous membrane will be tested.

Detailed description

This study is a randomized, single-center, cross-over, comparative bioavailability and adhesion study, comparing single administrations of a new scopolamine transdermal delivery system formulation to the current established reference transdermal delivery system in healthy adult participants. The study will consist of an ambulant screening day within 21 days prior to the first investigational medicinal product (IMP) administration at study Day 1 and two treatment periods. Each treatment period will consist of 4.5 days (108 hours) of in-house confinement.

Conditions

• Motion Sickness

Interventions

Type	Name	Description
DRUG	Reformulated scopolamine patch	Reformulated scopolamine patch of 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area with deliver approximately 1.0 mg over 72 hours
DRUG	Marketed scopolamine patch	Marketed scopolamine patch of 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area with delivery of approximately 1.0 mg over 72 hours.

Timeline

• Start date: 2016-05-13
• Primary completion: 2016-08-01
• Completion: 2016-08-10
• First posted: 2016-07-20
• Last updated: 2018-05-18

Locations

1 site across 1 country: Canada