evaluation of the pharmacokinetics of prana p1 capsules

Conditions: Healthy

Summary: this is a single dose clinical trial to assess the pharmacokinetics of two (2) dosages; 10 mg and 20mg of thc: thca of prana p1 bionutrients in healthy volunteers.

single oral dose, (10 mg prana p1 or 20 mg prana p1) in each period with a washout of 30 days between doses. patents will be randomly assigned dose for the first round of the study after a thirty-day washout, patient will return to the study site and receive cross over dose. metabolites to be measured: 1. thc 2. 11-oh-thc \[primary secondary metabolite of thc, psychoactive\] 3. thc-cooh \[inactive metabolite\] the following parameters for thc, 11-oh-thc, and thc-cooh will be assessed: auc0-t, auc0-inf, cmax, auct/inf, tmax. safety will be monitored and assessed through adverse events reports, 12-lead ecg, vital signs and laboratory parameters. each participant will undergo a psychometric evaluation using the chat assessment tool.

Eligibility criteria:
inclusion criteria: * males between 18 and 55 years. * body weight with a body mass index (bmi) range of 18.5 to 27.0 \[or weight within 15% of ideal weight for participant's height and frame * healthy, with normal findings in the physical examination and vital signs (bp between 100-140/60-90 mmhg, heart rate (hr) between 60 to 90 beats/min, respiration between 12 to 24 breaths/min) and no clinically-significant findings in a 12-lead ecg. * no clinical laboratory values outside of the laboratory normal reference range, unless the investigator determines them to be not clinically significant. * negative for hepatitis b surface antigen, hepatitis c antibody, hiv --willing and able to communicate well with the investigator and clinic staff, comply with the study procedure and schedule, and provide written informed consent. * able to understand the requirements of the study and sign informed consent. exclusion criteria: * current major axis i psychiatric disorder for which the participant is currently receiving treatment or which would make study compliance an issue. * any condition or therapy that, in the opinion of the investigator, may be significantly worsened by the exposure to marijuana. * acute disease at the time of enrolment (i.e., presence of a moderate or severe illness or infection with or without a fever). * febrile illness (oral temperature \>37.6° c at the time of drug administration). * unstable chronic illnesses. * chronic liver, renal or inflammatory bowel disease or collagen vascular disease. * clinically significant elevation of alanine transaminase(alt) and/or aspartate transaminase (ast). * active neurological disorder. * clinically significant uncontrolled illness or clinically significant surgery within 4 weeks prior to administration of study drug. * cancer within the previous 5 years, other than squamous cell or basal cell carcinoma of the skin. * difficulty to swallow study medication. * smoking more than 25 cigarettes per day. * history of any clinical laboratory abnormality deemed significant by the principal investigator. * history of serious adverse reaction or hypersensitivity to any drug. * bleeding tendency resulting from disease or medication rendering blood collection or the injection itself unsafe (use of antiplatelet agents is allowed). * coagulation disorders or receiving anticoagulant therapy. * inability to tolerate abstinence from caffeine for 24 hours prior to and during the study treatment phase. * consumption of alcohol within 24 hours prior to dosing and during the treatment phase. * history of significant alcohol or drug abuse within one year prior to the screening visit * chronic use (i.e., ≥3 days per week) of marijuana based products within 3 months prior to the screening visit. * use of hard recreational drugs (such as cocaine, phencyclidine \[pcp\] and crack) within one year prior to the screening visit. * donation of plasma (500 ml) within 7 days prior to drug administration * any known or suspected allergy to any constituent of marijuana. * any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigators, contraindicates the participant 's participation in this study. * use of any investigational or non-registered drug or participation in an investigational study within 30 days prior to administration of study drug.

Keywords: cannabis