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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00452894
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and/or female Chinese subjects between the ages of 18 and 45 years, inclusive.
* Body Mass Index (BMI) of approximately 19 to 24 kg/m2; and a total body weight ≥50 kg.
* Individuals who have smoked an average of at least 10 cigarettes per day during the past year, with no period of abstinence greater than 3 months in the past year.
Exclusion Criteria:
* Heart rate\>100 bpm, QRS Interval\>120 msec, QTc Interval \>430 msec, PR Interval\>220 msec, or any other abnormalities observed on the Electrocardiogram.
* Subjects with a sitting blood pressure of 140/90 mmHg or above at screening.
* Subjects with evidence or history of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurological disease, or any condition possibly affecting drug absorption.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00452894
Study Brief:
Protocol Section:
NCT00452894