Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of 2-mg lorazepam intravenous administration in healthy Japanese adult subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Lorazepam

Criteria

Inclusion Criteria:

• Healthy Japanese male and/or female subjects of non-childbearing potential.

• Body Mass Index of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.

Exclusion Criteria:

• History of sensitivity to lorazepam or other benzodiazepines.

• Evidence or history of acute narrow-angle glaucoma or sleep apnea syndrome.

• Significant psychiatric disorder, recurrent episodes of severe depression, or subjects with serious suicidal risk.