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NOT YET RECRUITING
NCT04396327
PHASE2

SM-1 vs. an Active Comparator in A Model of Transient Insomnia

Sponsor: Sequential Medicine Ltd

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the effectiveness, safety and tolerability of a combination drug product (SM-1) containing diphenhydramine, zolpidem and lorazepam, in adult participants who sometimes have difficulty in falling asleep or staying asleep, but who do not have chronic insomnia. Participants will receive SM-1 or a combination of diphenhydramine and lorazepam during 2 one-night stays at a sleep center.

Official title: A Randomized, Double-Blind, Single-Dose, 2-Way Cross-Over Study to Assess the Pharmacodynamic Effects of SM-1 vs. Active Comparator in a 3-Hour Phase Advance Model of Transient Insomnia

Key Details

Gender

All

Age Range

25 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2020-05-27

Completion Date

2020-06-30

Last Updated

2020-05-20

Healthy Volunteers

Yes

Interventions

DRUG

SM-1

diphenhydramine, zolpidem and lorazepam

DRUG

Active Comparator

diphenhydramine and lorazepam

Locations (1)

Clinilabs Drug Development Corporation

New York, New York, United States