Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
be a healthy man or woman, aged 18 to 55, and be neither too fat nor too thin;
If you are a woman who can have a baby, you must use an acceptable method of contraception, from the start of your last period before you take the study medicine, until you've had your first normal period after the end of the study. You might need to use contraception for longer than that. You don't need to use contraception if your partner has been sterilized (had an operation to cut the tubes that carry sperm).
Acceptable methods of contraception for women are:
Diaphragm or cap and condom with spermicide;
the 'Pill' and condom with spermicide - you must have been taking the 'Pill' for at least 3 months before the start of the study;
Intrauterine device (IUD or 'coil' - your GP must confirm that you have one) and condom with spermicide; or
Condom and spermicide only, if you're a woman who has had an operation to have your tubes tied.
If you are a woman who CANNOT have a baby, you should have gone through menopause at least 1 year ago;
had your womb removed; or
had both ovaries removed.
have normal physical exam
have normal blood pressure and pulse.
be able to swallow tablets;
show proof of identity - we'll tell you what's suitable.
have the ability to understand and comply with protocol requirements, instructions and restrictions.
be available to attend the ward for repeat tests, if necessary, during the 2 weeks after your final planned visit.
You may not be if
abuse alcohol or drugs;
drink, on average, more than 3 units of alcohol daily if you're a man, or 2 units if you're a woman (1 unit = ½ pint of beer, 1 small glass of wine or 1 measure of spirits);
have been a blood donor in the last 3 months;
have been given an experimental medicine in the last 3 months;
have taken part in a study of an experimental medicine in the last 3 months;
be a smoker, or have smoked cigarettes or used other tobacco products regularly in the last 6 months - we may test your breath for smoking at any time during the study;
be pregnant or breast feeding;
have had a serious reaction to any medicine;
have any screening test results that show you're not suitable, even if they don't mean that you're unhealthy;
have had any important illness (including diabetes and asthma) that, in the opinion of the study doctor, makes you unsuitable for the study;
have had any mental illnesses;
suffer from numbness or tingling in your arms, legs, hands or feet; or
has had glaucoma (increased pressure inside the eye).
You may not be able to take part if you've taken any medicines recently, including herbal remedies like St John's wort.
