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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT00973232
Eligibility Criteria:
Inclusion Criteria:
* Adult males or females aged 18-55 years inclusive with body mass index (BMI) between 18-30 kg/m2
* Healthy as determined by pre-study medical history, physical examination and 12-lead ECG
* Clinical laboratory tests within the reference ranges or clinically acceptable to the Investigator
* Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening
* Negative for drugs of abuse and alcohol at screening and admission
* Non-smokers for at least 3 months preceding screening
* If female, were not currently pregnant or breast feeding and were using medically acceptable methods of contraception and if male, were themselves and their female partners using medically acceptable methods of contraception
* Able and willing to give written informed consent.
Exclusion Criteria:
* Subjects who did not conform to the above inclusion criteria
* Female subjects who were pregnant, trying to become pregnant, lactating or not using acceptable methods of contraception
* Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
* Clinically relevant surgical history
* Clinically relevant family history
* History of relevant atopy
* History of relevant drug hypersensitivity
* History of alcoholism
* History of drug abuse
* Male subjects who consumed more than 21 units of alcohol a week and female subjects who consumed more than 14 units of alcohol a week
* Significant infection or known inflammatory process on screening
* Acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn)
* Acute infection such as influenza at the time of screening or admission
* Use of prescription drugs within 7 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor
* Use of over-the-counter medication excluding routine vitamins but including mega dose vitamin therapy within 14 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor
* Use of any investigational drug or participation in any clinical trial within 3 months of their first dosing
* Donation or receipt of any blood or blood products within the previous 3 months prior to first dosing
* Vegetarians, vegans or having medical or cultural dietary restrictions.
* Inability to communicate reliably with the Investigator.
* Subjects who were unlikely to co-operate with the requirements of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00973232
Study Brief:
Protocol Section:
NCT00973232