HealthyPhase 4NCT01256879
Cimetidine Biowaivers
A Phase 4 study testing Drug: cimetidine in people with Healthy, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Drug: cimetidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to May 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female
- Age 18-55
- Healthy volunteers: Subjects in good health, as determined by screening evaluation that is not greater than 30 days before the first drug study visit
- Willing to avoid caffeine containing products 24 hours prior to and day of study visits
- Willing to stop all over the counter medications for 24 hours prior to and during study visits
- Able to provide informed consent
Who cannot join
- Presence of significant medical disease (including cardiovascular, pulmonary, hematologic, endocrine, immunologic, neurologic, gastrointestinal or psychiatric)
- Presence of hepatic, renal disease
- Pregnant women, breast feeding or trying to become pregnant
- Excessive alcohol use (i.e. current physical, behavioral, or personal manifestations related to the abuse or dependency on alcohol)
- Routine use (i.e. daily or weekly) prescription medication except birth control pills
- Routine use (i.e. daily or weekly) use of acid blockers, antacids, anti-diarrhea, stimulants, appetite suppressants, or anti nausea medication or other drugs that modulate gastrointestinal function
Show all 10Show fewer
- Currently taking cimetidine or medication known to interact with cimetidine
- Allergic to cimetidine
- Undergoing therapy for solid tumor or blood malignancy
- Any condition in which in the opinion of the PI or medical physician would increase risk to the subject or interfere with the integrity of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Excipient Effects on Biopharmaceuticals Classification System (BCS) Class 3 Drug Cimetidine
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.
Read the detailed description
The investigators anticipate that common excipients do not cause bioINequivalence. 1) The hypothesize is that commonly used excipients in oral medications change the rate or extent of Class 3 drug absorption and result in bioINequivalence. 2) Alternative hypothesis is that commonly used excipients in oral medications do not change the rate or extent of Class 3 drug absorption and do not result in bioINequivalence.
- Conditions
- Healthy
- Being tested
- Drug: cimetidine
- Keywords
- cimetidine, pharmacokinetics, formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: cimetidineDrug
Also called Tagamet
cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution
| Study group | Role | What they receive |
|---|---|---|
| CimTest-A | Experimental | 200mg cimetidine (as 2 capsules) Receives: Drug: Drug: cimetidine |
| CimTest-B | Experimental | 200mg cimetidine (as 2 capsules) Receives: Drug: Drug: cimetidine |
| Sorbitol-free cimetidine solution | Active comparator | 200mg cimetidine (as oral liquid) Receives: Drug: Drug: cimetidine |
| Commercial cimetidine solution | Experimental | 200mg cimetidine (as oral liquid) Receives: Drug: Drug: cimetidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
pharmacokinetic exposure (ng*hr/ml)
Measured: 0-10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startMar 2011
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, James E Polli, University of Maryland, Baltimore
- Investigators
- James Polli, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256879
- Sponsor's protocol ID
- HP-00046139
- Other IDs
- HHSF2232000910020C
- Status last verified
- Aug 2019
- First submitted
- 15 Nov 2010
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rege BD, Yu LX, Hussain AS, Polli JE. Effect of common excipients on Caco-2 transport of low-permeability drugs. J Pharm Sci. 2001 Nov;90(11):1776-86. doi: 10.1002/jps.1127.
PubMed 11745735
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Excipient Effects on Biopharmaceuticals Classification System (BCS) Class 3 Drug Cimetidine
- ClinicalTrials.gov ID
- NCT01256879
- Acronym / sponsor ID
- HP-00046139
- Conditions
- Healthy
- Keywords
- cimetidine, pharmacokinetics, formulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- Mar 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators anticipate that common excipients do not cause bioINequivalence. 1) The hypothesize is that commonly used excipients in oral medications change the rate or extent of Class 3 drug absorption and result in bioINequivalence. 2) Alternative hypothesis is that commonly used excipients in oral medications do not change the rate or extent of Class 3 drug absorption and do not result in bioINequivalence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CimTest-A | Experimental | Drug: Drug: cimetidine200mg cimetidine (as 2 capsules) |
| CimTest-B | Experimental | Drug: Drug: cimetidine200mg cimetidine (as 2 capsules) |
| Sorbitol-free cimetidine solution | Active comparator | Drug: Drug: cimetidine200mg cimetidine (as oral liquid) |
| Commercial cimetidine solution | Experimental | Drug: Drug: cimetidine200mg cimetidine (as oral liquid) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or Female
- Age 18-55
- Healthy volunteers: Subjects in good health, as determined by screening evaluation that is not greater than 30 days before the first drug study visit
- Willing to avoid caffeine containing products 24 hours prior to and day of study visits
- Willing to stop all over the counter medications for 24 hours prior to and during study visits
Key exclusion criteria (10 listed)
- Presence of significant medical disease (including cardiovascular, pulmonary, hematologic, endocrine, immunologic, neurologic, gastrointestinal or psychiatric)
- Presence of hepatic, renal disease
- Pregnant women, breast feeding or trying to become pregnant
- Excessive alcohol use (i.e. current physical, behavioral, or personal manifestations related to the abuse or dependency on alcohol)
- Routine use (i.e. daily or weekly) prescription medication except birth control pills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug: cimetidineAlso: Tagametcimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution | Drug | CimTest-A, CimTest-B, Commercial cimetidine solution, Sorbitol-free cimetidine solution |
Primary outcome
AUC
Time frame: 0-10 hours
pharmacokinetic exposure (ng*hr/ml)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11745735Rege BD, Yu LX, Hussain AS, Polli JE. Effect of common excipients on Caco-2 transport of low-permeability drugs. J Pharm Sci. 2001 Nov;90(11):1776-86. doi: 10.1002/jps.1127.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Polli, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Drug: cimetidine in people with Healthy, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: 0-10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01256879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.