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

NCT02195804 | Completed Phase 1

• 1 other identifier: 1144.3
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  up to 16 hours after drug administration

• Maximum measured concentration of ranitidine in plasma (Cmax)

  up to 16 hours after drug administration

Secondary Outcomes (9)

• Area under the concentration-time curve of ranitidine in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)

  up to 16 hours after drug administration

• Time from dosing to the maximum concentration of ranitidine in plasma (tmax)

  up to 16 hours after drug administration

• Terminal rate constant in plasma (λz)

  up to 16 hours after drug administration

• Terminal half-life of ranitidine in plasma (t1/2)

  up to 16 hours after drug administration

• Mean residence time of the analyte in the body after po administration (MRTpo)

  up to 16 hours after drug administration

Study Arms (3)

Ranitidine HCL ODT Vanilla-Mint

EXPERIMENTAL

Drug: Ranitidine hydrochloride ODT

Ranitidine HCL ODT RM Vanilla-Mint

EXPERIMENTAL

Drug: Ranitidine hydrochloride ODT RM

Ranitidine HCL

ACTIVE COMPARATOR

Maximum Strength ZANTAC 150®

Drug: Ranitidine hydrochloride

Interventions

Ranitidine hydrochloride ODT DRUG

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

Ranitidine HCL ODT Vanilla-Mint

Ranitidine hydrochloride ODT RM DRUG

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

Ranitidine HCL ODT RM Vanilla-Mint

Ranitidine hydrochloride DRUG

Also known as: Maximum Strength ZANTAC 150®

Ranitidine HCL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Ranitidine

Intervention Hierarchy (Ancestors)

Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 21, 2014
• Study Start: May 1, 2009
• Primary Completion: June 1, 2009
• Last Updated: July 21, 2014

Record last verified: 2014-07