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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT02660060
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female subjects
* Preferably non-smokers or smoke less than 10 cigarettes per day
* Body mass index within 18 to 25 kg/m2
* Normal vital signs (after 10 minutes rest): systolic blood pressure 100 - 120 mmHg, diastolic blood pressure 60 - 80 mmHg, pulse rate 60 - 90 bpm
Exclusion Criteria:
* Personal / family history of allergy or hypersensitivity or contraindication to pramipexole or allied drugs
* Pregnant or lactating women
* Any major illness in the past 90 days or clinically significant ongoing chronic medical illness
* Any clinically significant abnormal values of liver function test (ALT, alkaline phosphatase, total bilirubin \>= 1.5 upper limit normal), renal function test (serum creatinine \> 1.4 mg/dL), etc
* Positive Hepatitis B surface antigen (HbsAg), anti-HCV, or anti-HIV
* Clinically significant hematology abnormalities
* Clinically significant ECG abnormalities
* Any surgical or medical condition (present or history) which might significantly alter the pharmacokinetics of the study drug
* History of anaphylaxis or angioedema
* History of drug or alcohol abuse within 12 months prior to screening
* Participation in any clinical trial within the past 90 days
* History of any bleeding or coagulative disorders
* History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm
* A donation or loss of 300 mL (or more) of blood within 3 months before the study's first dosing day
* Intake of any prescription, non-prescription drug, food supplement or herbal medicine within 14 days of the study's first dosing day
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02660060
Study Brief:
Protocol Section:
NCT02660060