Food effect and pharmacokinetics study in healthy, male volunteers with P2202
- Registration Number
- CTRI/2010/091/002992
- Lead Sponsor
- Piramal Enterprises Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
Healthy male human volunteers within the age range of 18 to 55 years (both inclusive)
-Non-smokers since at least six months
-Willingness to provide written informed consent to participate in the study
-Body-mass index of at least 18.5 kg/m2 and less than or equal to 24.9 kg/m2, with body weight not less than 50 kg
-Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening
-Normal 12-lead ECG or one with abnormality considered to be clinically insignificant
-Normal chest X-ray PA view
-Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol
-Able and willing to complete the high-fat high-calorie breakfast required for the study
-Personal/family history of allergy or hypersensitivity to P2202 or related drugs or any of the excipients
-Past history of anaphylaxis or angioedema, bronchial asthma and peptic ulcer
-Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc.
-Presence of any clinically significant abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT) etc.
-Any cardiac, renal or liver impairment, any other organ or system impairment
-History of seizure or psychiatric disorders
-Presence of disease markers of HIV 1 and 2, HBsAg and hepatitis C virus
-Consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study [one drink is equal to one unit of alcohol [one glass wine, half pint beer, and one measure (one ounce) of spirit]
-Consumption of xanthine-containing derivatives (coffee, tea, cola drinks, chocolate) within 48 hours prior to the check-in of each period
-Use of any recreational drug or a history of drug addiction
-Participation in any clinical trial within the past 3 months
-Inaccessibility of veins in left and right arm
-Donation of blood (one unit or 350 mL) within 3 months prior to receiving the first dose of study medication
-Use of any prescription drug therapy within four weeks or over-the-counter (OTC) drugs within two weeks prior to receiving the first dose of study medication or repeated use of drugs within the last four weeks
-An unusual diet, for whatever reason e.g. low sodium diet, for two weeks prior to receiving any study medication and throughout subject?s participation in the study
-Consumption of grapefruit-containing food or beverages within 7 days prior to receiving the first dose of study medication in both periods
-Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 7 days prior to the study
-Volunteers, who observe religious fasting.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method