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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT00954356
Eligibility Criteria:
Inclusion Criteria:
* Males (aged 18-60) and females of non-childbearing potential (aged 18-60;
* BMI between 19.5 to 32.0 kg/m2;
* Outpatient, scheduled to undergo surgical extraction of 2 or more impacted 3rd molars (with at least 1 partial bony mandibular extraction);
* use of only the following preoperative medications 2% lidocaine with epinephrine and nitrous oxide;
* Able to complete the requested information on analgesic questionnaires and able to comply with study procedures and restrictions;
* Able to read, comprehend and sign the consent form;
* Deemed medically healthy to participate in the study, with normal or clinically insignificant medical history, physical examination, lab tests and ECG results;
* No contraindications to the study drug, it excipients or any of the study medications including rescue medications.
Exclusion Criteria:
* Presence of a clinically significant medical condition;
* Positive test for HIV, Hepatitis B or Hepatitis C;
* Use of any prescription or over the counter medication or supplement in the 48 hours before dose of study drug until discharge;
* Acute local infection at the time of dental surgery;
* Females who are pregnant, lactating or of child-bearing potential, or who provide a positive pregnancy test result at screening or check-in;
* Males not undertaking adequate measures to prevent their partner becoming pregnant throughout the study;
* Clinically significant laboratory values;
* Clinically significant abnormal ECG;
* History or presence of alcoholism, or alcohol or substance abuse (within previous 2 years), or routine consumption of 3 or more alcoholic drinks per day;
* A positive urine drug test;
* Routine use of analgesics 5 or more times per week;
* Presence or history (within 2 years of enrolment) of bleeding disorder(s) or peptic ulcer disease;
* History of allergic reaction to any drug, including penicillin;
* Ingestion of caffeine containing foods or drinks in the 24 hours before dose of study drug;
* Consumption of alcohol in the 48 hours before dose of study drug, or a positive alcohol breath test at check-in;
* Consumption of grapefruit or grapefruit containing products in the 7 days before dose of study drug;
* Use of tobacco or nicotine substitutes within 1 month of dose of study drug, or inability to refrain from use of nicotine between check-in and follow up;
* Treatment for depression in the 6 months prior to enrolment;
* Use of another investigational drug in the 60 days before enrolment;
* Donation or loss of 50-500 mL of blood in the 30 days prior to enrolment, or more than 500 mL of blood in the 56 days before enrolment;
* Previously entered into this study;
* Study site or Sponsor employees or relatives of employees directly involved in the study;
* Any other condition that (in the opinion of the Investigator or sponsor) makes the subject unsuitable for the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00954356
Study Brief:
Protocol Section:
NCT00954356