Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT01821235
Eligibility Criteria:
Inclusion Criteria:
* Healthy males and females aged between 18 and 55 years at screening, extremes included.
* A Body Mass Index of 18.0 to 30.0 kg/m².
* Good physical and mental health.
* Subject is a non-smoker for at least 3 months prior to dosing.
Exclusion Criteria:
* Clinically relevant abnormal laboratory, ECG recordings, vital signs or physical findings at screening as judged by the investigator.
* History of hypersensitivity or idiosyncrasy to gabapentin or any other anti-convulsive agents.
* Positive serology for hepatitis B antigen, hepatitis C antibodies, HIV 1 or HIV 2 antibodies.
* History of alcohol or drug abuse within the last 2 years.
* Blood donation within 1 month before screening.
* Female subjects who are pregnant or lactating.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01821235
Study Brief:
Protocol Section:
NCT01821235