All clinical trials have guidelines about who can participate.

Some of the standard guidelines are as follows:

• Testing for drugs of abuse such as cannabinoids (Marijuana), amphetamines, benzodiazepines and opiates (ie morphine, heroin, codeine) will be carried out as part of the screening process.
• Alcohol breath testing will be carried out at the commencement of each phase of the study.
• You will be required to fast from 10:00 pm on the night before the study until approximately 1.00 pm on the first day of each phase of the study.
• You are required to stay at the ZenTech Clinical Site from 8.00 pm on the Friday night prior to dosing in each phase of the study.
• You will be given a study timetable which details the timing of all events which will occur in the study.
• Before beginning the study you will undergo a routine physical examination by a medical practitioner, who may be male or female. At your medical examination, a family or whanau member, a friend or chaperone may be present with you in the examination room if you wish.
• An electrocardiograph (ECG) recording will be made to assess your heart and your blood pressure will also be measured.
• Blood samples will be taken before and after the study to enable an assessment to be made of your kidney and liver functions as well as haematological profiles.
• Females will be required to undergo a blood pregnancy test before, during and at the completion pof the study. In most instances females are premitted to keep taking oral contraceptives.
• A test for Hepatitis A, B and C and HIV will also be performed before the study.
• Your participation is voluntary and you are free to withdraw from a study at any time

What happens during a study

When you have been through the screening evaluation, blood tests, medical examination and have been accepted onto the study the following procedures will take place:

Pre-dosing

• You will be requreid to fast for at least 10 hours before receiving your dose.
• You will be required to stay at the ZenTech Clinical site from 8.00 pm on the night before dosing on each phase to ensure fasting conditions have been met.
• You will be required to adhered to the following study conditions.
• No other medication (including vitamins, natural remedies and non-prescribed medication) should be consumed for the two weeks prior to the study or during the study except for prescribed oral contraceptives.
• Alcohol must not be consumed for 48 hours before the study and throughout the medication taking period.
• You must not consume any drinks or substances containing caffeine and chocolate for 48 hours prior to dosing and throughout the medication taking period - tea and coffee.

Dosing

• You must maintain an upright position for at least 4 hours
• You may be required to fast for an addition 5 hours after dosing
• You can drink water from 1 hour after dosing
• You will be required to stay at the ZenTech Clinical Site for a specified period of time in each phase of the study (generally not exceeding 24 hours after dosing)
• During your stay at the ZenTech Clinical Site blood samples will be taken at specified intervals

Post-dosing

• The procedures involved vary depending on the drug being taken and the number of blood samples required post dosing.
• Engaging in strenuous physical activity during the study days is not permitted as the drug could effect your co-ordination and concentration.
• Following dosing you will not be permitted to leave the study site until the allocated time.