Influence of pregabalin and lacosamide on the respiratory depression caused by oxycodone

Phase 1

• Conditions: Healthy Volunteers; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2022-001603-40-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-21
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

- aged 18-45 years,
- body mass index < 30 kg.m-2,
- able to understand the written informed consent form,
- able to communicate with the staff,
- able and willing to complete the study procedures,
- signed the informed consent form,
- deemed suitable by the investigators.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Presence or history of any medical or psychiatric disease (incl. a history of substance abuse, anxiety, or the presence of a painful syndrome such as fibromyalgia);
- Use of any medication in the three months prior to the study (incl. paracetamol or other pain killers);
- Use of more than 21 alcohol units per week;
- A positive urinary drug test or a breath alcohol test at screening or on the morning of the experiment;
- Pregnancy, lactating or a positive pregnancy test on the morning of the experiment;
- Participation in another drug trial in the 60 days prior to dosing.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified