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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ranitidine hydrochloride ODT RM; Drug: Ranitidine hydrochloride; Drug: Ranitidine hydrochloride ODT

Study type: Interventional

Funder types: Industry

Identifiers

NCT02195804

1144.3

Details and patient eligibility

About

The objective of this study is to establish the relative bioavailability (BA) of two different ranitidine hydrochloride 150 mg ODT formulation in comparison to the current, over the counter (OTC) ranitidine hydrochloride (Maximum Strength ZANTAC 150®) formulation following oral single dose administration in fasting healthy male volunteers

Enrollment: 42 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Ranitidine HCL ODT Vanilla-Mint

Experimental group

Treatment:

Drug: Ranitidine hydrochloride ODT

Ranitidine HCL ODT RM Vanilla-Mint

Experimental group

Treatment:

Drug: Ranitidine hydrochloride ODT RM

Ranitidine HCL

Active Comparator group

Description:

Maximum Strength ZANTAC 150®

Treatment:

Drug: Ranitidine hydrochloride