At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 25 enrolled

Drug / intervention

Drug: cimetidinedrug

Likely dose

Drug: cimetidine 200mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01256879

NCT01256879Phase 4Completed

Compare CT.gov

Evaluation of Excipient Effects on Biopharmaceuticals Classification System (BCS) Class 3 Drug Cimetidine

University of Maryland, Baltimore·interventional·Posted Dec 9, 2010·Updated Aug 28, 2019

In Brief

A Phase 4 clinical trial evaluating Drug: cimetidine for Healthy. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHealthy

CountriesUnited States

CollaboratorsFood and Drug Administration (FDA)

Timeline

Phase 4CompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

First PostedDec 2010

Enrollment StartMar 2011

Primary CompletionApr 2014

Study CompletionMay 2014

TodayJul 2026

First PostedDec 9, 2010

Enrollment StartMar 1, 2011

Primary CompletionApr 1, 2014

Study CompletionMay 1, 2014

TodayJul 2, 2026

Enrollment to primary: 3.1 yearsPosted 15.6 years ago

Interventions

Drug: cimetidinedrug

cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution