Evaluation of the Pharmacokinetics of Prana P1 Capsules

• 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.