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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT01220167
Eligibility Criteria:
Inclusion Criteria:
The criteria for inclusion in the study were:
* Study volunteer should provide written informed consent.
* Study volunteer must be a healthy adult within 18-45 years of age (inclusive).
* Study volunteer should have a Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
* Study volunteer should have a systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.
* Study volunteer must be of normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.
* Study volunteer should have a normal ECG, chest X-ray and vital signs.
* If study volunteer is a female and is of child bearing potential she must be practicing an acceptable method of birth control for the duration of the study.
Exclusion Criteria:
The criteria for exclusion from the study were:
* Study volunteer incapable of understanding the informed consent.
* Study volunteer with a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
* Study volunteer having any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
* Study volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma
* Study volunteer who smokes regularly more than ten cigarettes daily.
* Study volunteer who has taken over the counter or prescribed medications.
* Study volunteer with a history of any psychiatric illness, which may impair the ability to provide written, informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01220167
Study Brief:
Protocol Section:
NCT01220167