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:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT00952094
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects aged 20 - 35 years
* A body mass index (BMI) in the range 19-27 kg/m2
* Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully informed about the study procedures.
* Subject who didn't drink grapefruit within 3 days prior to the test drug dosing
* Subject judged eligible for study participation by investigator considering screening result except PTH
Exclusion Criteria:
* Clinically relevant abnormal medical history that could interfere with the objectives of the study.
* A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
* Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
* Presence or history of drug or alcohol abuse.
* Participation in other clinical trial within 3 months (in case of bioequivalence study or other clinical trial) or within 4 months (in case of phase 1 study) or with 1 month (in case of patch) prior to scheduled study drug administration (measured from the final dosing day in the previous trial)
* Use of a prescription medicine, herbal medicine or over-the-counter medication within 7 days before first dose
* Use of medication or food which induces or inhibits CYP2D6 or CYP3A4 within 1 month prior to the test drug dosing (except food contain grapefruit)
* Loss of more than 400 mL blood during the 3 months or 200ml during the 1 month before the study, or apheresis during 2 weeks before the study.
* Subject judged not eligible for study participation by investigator
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
35 Years
Study:
NCT00952094
Study Brief:
Protocol Section:
NCT00952094