TP0501 - Pharmaco-Scintigraphic-Study

Inclusion criteria

• Healthy subjects, male or non-pregnant, non-lactating females, between 18 and 55 years old. Females of child bearing potential must have a negative serum pregnancy test prior to the intake of study drug, and must use a hormonal (oral, implantable or injectable) or a double barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
• Ability of subject to participate fully in all aspects of this clinical trial.
• Voluntarily signed informed consent must be obtained and documented.

Exclusion criteria

• Participating in a clinical study involving investigational drugs or dosage forms within the previous 2 months.
• History of alcohol or drug abuse.
• Radiation exposure from clinical trials, including that from the present study and from diagnostic X-ray but excluding background radiation, exceeds 5 mSV in the last 12 months or 10 mSv in the last 5 years. No subject whose occupational exposure is monitored will participate in the study.
• Any nuclear medicine procedure prior to study day 1 that might interfere with the scintigraphic images that are acquired.
• Clinically significant abnormal biochemistry, haematology or urine analyses:

• White blood count < 3 x 109/L and > 8 x 109/L
• Lymphocyte count < 0.85 x 109/L
• Haemoglobin < 110 g/L
• Platelet count < 125 x 109/L or > 600 x 109/L
• Alanine-Aminotransferase (ALT) or Aspartate-Aminotransferase (AST) > 2x upper limit normal
• Alkaline Phosphatase > 2x upper limit normal
• Serum Creatinine > upper limit normal
• History of gastrointestinal surgery, with the exception of appendectomy unless it was performed within the previous 12 months.
• History of cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome (within the previous 12 months).
• History of adverse reaction or allergy to Mesalazine or other salicylates.
• Acute diarrhoea or constipation in the 14 days before the predicted first study day. If screening occurs >14 days before first study day, this criterion is to be determined on the first study day. Diarrhoea will be defined as the passage of liquid faeces and/or qa stool frequency of > 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day.
• Donation of blood within the previous three months.
• Positive HBV-Antigen (Hepatitis-B), HCV-Antibody (Hepatitis-C) or HIV-Antibody (Human Immunodeficiency Virus) results.
• Over-the-counter (OTC) and prescription medication (including laxatives, vitamin-pills and natural herbal remedies) between screening visit (visit 1) and completion of the study. Occasional paracetamol or acetyl-salicyl-acid is permitted.
• Failure to satisfy the Principle Investigator to participate for any other reason.