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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT00542035
Eligibility Criteria:
Key Inclusion Criteria:
* Scheduled for outpatient oral surgical procedure to remove 2 ipsilateral third molars, at least 1 of which is mandibular and fully or partially impacted by bone.
* Females of childbearing potential must be willing to use an acceptable method of contraception within 14 days prior to first dose of study drug until the completion of the follow-up procedures.
* Body weight \>50 kg (110 lbs).
* Good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance.
* Additional criteria exist.
Key Exclusion Criteria:
* Positive urine drug screen.
* Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins, or grapefruit juice within 14 days prior to first dose of study drug.
* Additional criteria exist.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00542035
Study Brief:
Protocol Section:
NCT00542035