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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01256879
The ClinicalTrials.gov registry entry for NCT01256879 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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