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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01118702
Eligibility Criteria:
Inclusion Criteria:
* The volunteer will be assessed against all protocol specified criteria at investigator site: If a female, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives for at least 3 months, contraceptive injections, intrauterine device, contraceptive patch, male partner sterilization) before entry, throughout the study, and 1 week after the completion of the study
* if female, must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at screening and on Day -1 of each treatment period
* Body mass index (weight \[kg\]/height \[m2\]) between 18 and 30 kg/m2 (inclusive)
* Body weight not less than 50 kg
* Blood pressure (after the patient is sitting for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and 50 and 90 mmHg diastolic, inclusive
Exclusion Criteria:
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, birth control (prescription oral contraceptives, contraceptive injections, intrauterine device, contraceptive patch), and hormonal replacement therapy within 14 days before the first dose of the study drug
* Current, history or a reason to believe a subject has a history of drug or alcohol abuse/dependence according to DSM-IV
* Positive test for drugs of abuse
* Known allergy to the study drug or any of the ingredients in the study drug tablets
* Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half life, whichever is longer, before the first dose of the study drug - a drug's half life is the time that it takes the body to excrete 50% of the drug
* Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
* If a female, breast-feeding or planning to become pregnant during the study or within 60 days of last study drug
* Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies administration
* History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or patient's verbal report
* May not consume food or beverages containing alcohol, grapefruit juice, Seville oranges, or quinine (e.g., tonic water) from 24 hours (72 hours in the case of grapefruit juice and Seville oranges) before each PK sample collection day, until after the last PK sample is collected in each period
* Must refrain from the use of any methylxanthine-containing products, (e.g., chocolate bars or beverages, coffee, teas, or colas) from 48 hours before administration of study drug and during confinement, and when caffeine is allowed, must avoid excessive use of caffeine (i.e., no more than approximately 500 mg/day, as contained in 5 cups of tea or coffee or 8 cans of cola), during the entire study (from screening to end of study)
* May not consume food containing poppy seeds during the study
* Must refrain from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch) throughout the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01118702
Study Brief:
Protocol Section:
NCT01118702