Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.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.History of pre-existing bleeding disorder.History of significant blood loss due to any reason, including blood donation in the past 3 months.Administration of any study drug in the period 0 to 3 months before entry to the study.Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - Cocaine positive volunteers based on urine test.Volunteers suffering from any chronic illness such as arthritis, asthma etc.History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.Recent history of kidney or liver dysfunction.History of allergy to the test drug or any drug chemically similar to the drug under investigation.Respiratory rate less than 12/minute or more than 20/minute.Oral temperature less than 95°P or more than 98.6°P.Pulse rate less than 50/minute or more than 100/minute.Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.Clinically significant abnormal ECG or Chest X-ray.Clinically relevant abnormalities in the results of the laboratory screening evaluation.The volunteers were excluded from the study based on the following criteria: Non-smokers or smoker who smokes less than 10 cigarettes per day.Volunteer willing to adhere to the protocol requirements and to provide written informed consent.Healthy and willing to participate in the study.Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.The volunteers were included in the study based on the following criteria: Why Should I Register and Submit Results?.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |