Pharmaco-Scintigraphic Study to Evaluate the Release Profile of Metronidazole Benzoate Capsules

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 urine 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 with as a minimum of one year since the last menstrual period).
• Ability of subject to participate fully in all aspects of this clinical trial.
• Voluntary signed informed consent must be obtained and documented.
• Accept not to use any kind of tobacco, including cigarettes nor E-Cigarettes or pipe smoking, nicotine replacements nor oral tobacco and not to consume any alcohol or drugs during screening, treatment and following two days.

Exclusion criteria

• Participating in a clinical study involving investigational drugs or dosage forms within the previous 30 days.
• 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 five 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 deviation of biochemistry or haematology parameters from the normal range
• History of gastrointestinal surgery, with the exception of appendectomy unless it was performed within the previous 12 months.
• Clinically relevant cardiovascular, renal, hepatic, metabolic, autoimmune, pulmonary and particularly gastrointestinal diseases, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease or Irritable Bowel Syndrome (within the previous 12 months).
• 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 a stool frequency of greater than three times per day. Constipation will be defined as a failure to defecate more frequently than every three days.
• History of adverse reaction or allergy to metronidazole or any study drug or formulation components/ingredients.
• Hypersensitivity to imidazole derivatives
• History of any malignancy removed or adequately treated.
• History of alcohol or drug abuse.
• Donation of blood (or plasma) within the previous three months and donation of Plasma the last 14 days.
• Over-the-counter (OTC) and prescription medication (including laxatives, vitamins and natural herbal remedies including St. John's Wort) between screening visit (visit 1) and completion of the study. Occasional paracetamol or acetyl-salicylic acid is permitted.
• Ingestion of grapefruit juice, coffee, caffeine containing beverages on treatment day.
• Failure to satisfy the Investigator to participate for any other reason.
• Known allergy to crustaceans (due to Chitosan)