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NCT01907776 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Safety Study of ME1100 in Healthy Volunteers
A Phase 1 study, sponsored by Meiji Seika Pharma Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT01907776 is a Phase 1 study that has completed, run by Meiji Seika Pharma Co.. The registered enrollment target is 56 participants.
The verdict
NCT01907776, a Phase 1 study, has completed, sponsored by Meiji Seika Pharma Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
This is a single-center, randomized, double-blind, placebo-controlled, sequential group study. The primary objective of this study is to assess the tolerability and safety of single doses of ME1100 inhalation solution (orally inhaled arbekacin). The secondary objective is to determine the systemic exposure to, and urinary elimination of, ME1100.
Interventions
- DRUG ME1100 inhalation solution
- DRUG ME1100 placebo inhalation solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2013-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01907776
The ClinicalTrials.gov registry entry for NCT01907776 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Meiji Seika Pharma Co., which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ME1100 inhalation solution is the first listed.
NCT01907776 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01907776 about?
NCT01907776 is a clinical study titled "Pharmacokinetics and Safety Study of ME1100 in Healthy Volunteers". This is a single-center, randomized, double-blind, placebo-controlled, sequential group study. The primary objective of this study is to assess the tolerability and safety of single doses of ME1100 inhalation solution (orally inhaled arbekacin). The secondary objective is to determine the systemic e...
What is the current status of trial NCT01907776?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2013-07.
What interventions are being tested in trial NCT01907776?
The interventions under investigation include: ME1100 inhalation solution (DRUG), ME1100 placebo inhalation solution (DRUG).
Who is sponsoring clinical trial NCT01907776?
This trial is sponsored by Meiji Seika Pharma Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
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