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

NCT ID: NCT02195804

Last Updated: 2014-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ranitidine HCL ODT Vanilla-Mint

Group Type: EXPERIMENTAL

Ranitidine hydrochloride ODT

Intervention Type: DRUG

Ranitidine hydrochloride ODT#1 150 mg (Vanilla-Mint)

Ranitidine HCL ODT RM Vanilla-Mint

Group Type: EXPERIMENTAL

Ranitidine hydrochloride ODT RM

Intervention Type: DRUG

Ranitidine hydrochloride ODT Reduced Mannitol (RM) 150 mg Vanilla-Mint (ODT#2)

Ranitidine HCL

Maximum Strength ZANTAC 150®

Group Type: ACTIVE_COMPARATOR

Ranitidine hydrochloride

Intervention Type: DRUG

Interventions

Ranitidine hydrochloride ODT

Ranitidine hydrochloride ODT#1 150 mg (Vanilla-Mint)

Intervention Type: DRUG

Ranitidine hydrochloride ODT RM

Ranitidine hydrochloride ODT Reduced Mannitol (RM) 150 mg Vanilla-Mint (ODT#2)

Intervention Type: DRUG

Ranitidine hydrochloride

Intervention Type: DRUG

Other Intervention Names

Maximum Strength ZANTAC 150®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1144.3

Identifier Type: -

Identifier Source: org_study_id