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Oral Remimazolam With and Without Alcohol in Healthy Female Subjects

NCT04113343 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-10-02

No results posted yet for this study

Summary

A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects

Conditions

  • Safety Issues

Interventions

DRUG

Remimazolam

Remimazolam via oral administration

OTHER

Alcohol

Alcohol

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Paion UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Ahad Sabet, MD · PRA Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2017-08-09
Completion
2017-08-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04113343 on ClinicalTrials.gov