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NCT01256879 · ClinicalTrials.gov registry record · Phase 4
Cimetidine Biowaivers
A Phase 4 study of Healthy, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT01256879: Completed Phase 4 study of Healthy, sponsored by University of Maryland, Baltimore.
NCT01256879 is a Phase 4 study of Healthy that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 25 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01256879, a Phase 4 study of Healthy, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
pharmacokinetic exposure (ng\*hr/ml)
Conditions Studied
Interventions
- DRUG Drug: cimetidine
Study Locations (1)
Maryland
- University of Maryland - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-05 |
| Phase | Phase 4 |
What the finished NCT01256879 record still lists
NCT01256879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Drug: cimetidine is the first listed.
NCT01256879 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01256879 about?
NCT01256879 is a clinical study titled "Cimetidine Biowaivers". 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 solut...
What is the current status of trial NCT01256879?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2011-03. Estimated completion is 2014-05.
What conditions does trial NCT01256879 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01256879?
The interventions under investigation include: Drug: cimetidine (DRUG).
Who is sponsoring clinical trial NCT01256879?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01256879 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01256879's enrollment target sits among peer trials
25 778th of 1090 higher than 301 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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