Pharmacokinetic and pharmacodynamic profile of midazolam intranasal spray in elderly volunteers.

Completed

• Conditions: Anesthesia; is to diminish the patients instinctive protective responses.

• Registration Number: NL-OMON49143
• Lead Sponsor: QPS Netherlands B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1. Adult, men and women (of non-childbearing potential), aged from 65 to 90
years old (both inclusive).
2. Body Mass Index (BMI) * 18 and * 30 kg/m², inclusive, and a total body
weight >50 kg, at screening and check-in.
3. American Society of Anesthesiologists (ASA) Physical Status 1 or 2
4. Understand the study procedures in the informed consent form(s) (ICF(s)),
and be willing and able to comply with the protocol.

Exclusion Criteria

1. Current use of midazolam
2. Contraindications for the use of midazolam
3. History or presence of significant cardiovascular disease (ASA >2), or
significant cardiovascular disease risk factors, significant coronary artery
disease, or any known genetic pre disposition to cardiac arrhythmia (including
long QT syndrome.)
4. History or presence of significant (ASA >2) pulmonary, hepatic, renal,
hematological, gastrointestinal, endocrine, immunologic, dermatologic,
neurological (inclusive of any seizure disorder), or psychiatric disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified