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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-07-21

No results posted yet for this study

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

Interventions

DRUG

Ranitidine hydrochloride ODT

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

DRUG

Ranitidine hydrochloride ODT RM

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

DRUG

Ranitidine hydrochloride

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02195804 on ClinicalTrials.gov