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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT03517033
Eligibility Criteria:
Inclusion Criteria:
* Sex: male
* Age: 18-45 years (inclusive both)
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day.
Exclusion Criteria:
* Inability to communicate or co-operate.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of pre-existing bleeding disorder.
* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* HIV, HCV, HBsAg positive volunteers.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* Participation in any study within past 3 months before entry to the study,
* History of alcohol or drug abuse.
* History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study.
* Positive to breath alcohol test.
* Volunteer found to be positive for Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Systolic blood pressure less than 100 mmHg or more than 140 mmHg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute.
* Oral temperature less than 95°F or more than 98.6°F.
* Respiratory rate less than 12/minute or more than 20/minute.
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* Recent History of kidney or liver dysfunction.
* Volunteers suffering from any psychiatric (acute or chronic) disorder.
* Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03517033
Study Brief:
Protocol Section:
NCT03517033