Trial · NCT01256879
Cimetidine Biowaivers
NCT01256879, Phase 4, Completed, University of Maryland, Baltimore; results first posted 2019-08-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cimetidine Biowaivers. Trials, record NCT01256879. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01256879
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cimetidine Biowaivers
- NCT number
- NCT01256879
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 25 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Healthy
- Interventions
- Drug: cimetidine
- First posted
- 2010-12-09
- Last updated
- 2019-08-28
- Results first posted
- 2019-08-28
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | AUC | 0-10 hours | pharmacokinetic exposure (ng\*hr/ml) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | AUC | 0-10 hours | ng*hr/ml | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| AUC | Experimental: CimTest-A | 3896 | Standard Error 181 | ng*hr/ml | |
| AUC | Experimental: CimTest-B | 3661 | Standard Error 186 | ng*hr/ml | |
| AUC | Active Comparator: Sorbitol-free Cimetidine Solution | 3495 | Standard Error 183 | ng*hr/ml | |
| AUC | Experimental: Commercial Cimetidine Solution | 3512 | Standard Error 193 | ng*hr/ml |
Source ClinicalTrials.gov
Participant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cimetidine | 25 | |
| Overall Study | CimTest-A | Cimetidine | 25 | |
| Overall Study | CimTest-B | Cimetidine | 24 | |
| Overall Study | Sorbitol-free Cimetidine Solution | Cimetidine | 24 | |
| Overall Study | Commercial Cimetidine Solution | Cimetidine | 24 | |
| Overall Study | COMPLETED | Cimetidine | 24 | |
| Overall Study | NOT COMPLETED | Cimetidine | 1 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | pain | Skin and subcutaneous tissue disorders | Experimental: CimTest-A | 1 | 25 | 1 |
| other | pain | Skin and subcutaneous tissue disorders | Experimental: CimTest-B | 0 | 24 | 0 |
| other | pain | Skin and subcutaneous tissue disorders | Active Comparator: Sorbitol-free Cimetidine Solution | 0 | 24 | 0 |
| other | pain | Skin and subcutaneous tissue disorders | Experimental: Commercial Cimetidine Solution | 0 | 24 | 0 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental: CimTest-A | 0 | 25 |
| Total, all-cause mortality | Experimental: CimTest-B | 0 | 24 |
| Total, all-cause mortality | Active Comparator: Sorbitol-free Cimetidine Solution | 0 | 24 |
| Total, all-cause mortality | Experimental: Commercial Cimetidine Solution | 0 | 24 |
| Total, other adverse events | Experimental: CimTest-A | 1 | 25 |
| Total, other adverse events | Experimental: CimTest-B | 0 | 24 |
| Total, other adverse events | Active Comparator: Sorbitol-free Cimetidine Solution | 0 | 24 |
| Total, other adverse events | Experimental: Commercial Cimetidine Solution | 0 | 24 |
| Total, serious adverse events | Experimental: CimTest-A | 0 | 25 |
| Total, serious adverse events | Experimental: CimTest-B | 0 | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 11745735 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01256879
GET https://conductscience.org/api/trials/v1/NCT01256879/registered