DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Lorazepam (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

Official title: A Phase 1, Randomized Single-blind (Subject-blind), Placebo Controlled Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Primary outcome: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).

Secondary outcome:

Maximum Observed Plasma Concentration (Cmax)

Area under the Concentration-Time Curve (AUC)

Eligibility

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Hachioji-shi, Tokyo, Japan
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: January 2014
Last updated: February 28, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017