Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®) Compared to Two Different 150 mg Ranitidine Hydrochloride Oral Disintegrating Tablet (ODT) in Fasting, Healthy Male Volunteers

Inclusion criteria

• Healthy male subjects based on: complete medical history, including a physical examination, vital signs (pulse rate (PR), systolic & diastolic blood pressure (BP) and body temperature), 12-lead electrocardiogram (ECG) and clinical laboratory tests
• Age ≥ 18 and Age ≤ 60 years
• BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index) and body weight of ≥ 55 kg
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion criteria

• Any clinically relevant abnormality found on the screening physical examination (including BP, PR) or ECG or in the opinion of the investigator the patient is not suitable for the study
• Any evidence of an acute or chronic gastrointestinal conditions or relevant concomitant medical disease
• History of acute porphyria
• History of peptic ulcer disease
• Heartburn requiring treatment (OTC or prescription medicine) within the last 30 days
• History of surgery of the gastrointestinal tract surgery (except appendectomy and cholecystectomy)
• History of relevant allergy / hypersensitivity (including allergy to H2 inhibitor) to the drug class, ranitidine hydrochloride or its excipients)
• Intake of prescription or over-the-counter (OTC) drugs with a long half-life (>24 hours) within at least 2 weeks or less than 10 half-lives of the respective drug prior to administration or during the trial
• Participation in another trial with an investigational drug within 30 days prior to administration or during the trial
• Inability to refrain from alcohol use 48 hours prior to drug administration until the end of the study visit for each treatment period
• History of alcohol (more than 60 g/day) or drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Any laboratory value outside the reference range that is of clinical relevance as determined by the investigator
• Inability to comply with dietary regimen of trial site
• Subjects who test positive upon drug screening
• Subjects who consume caffeine or xanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.) 48 hours prior to study drug administration
• Subjects who consume citrus fruits and juices, (in particular grapefruits and Seville oranges, sour or bitter oranges), or products containing St. John's wort (Hypericum perforatum) are not allowed 7 days prior to dose administration
• Excessive physical activity or exercise (such as organized sports) during the trial period