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NCT01189396 · ClinicalTrials.gov registry record · Phase 2
Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006
A Phase 2 study, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT01189396 is a Phase 2 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 27 participants.
The verdict
NCT01189396, a Phase 2 study, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical dose.
Interventions
- DRUG Placebo DPI
- DRUG A006
- DRUG Proventil-HFA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01189396
The ClinicalTrials.gov registry entry for NCT01189396 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amphastar Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo DPI is the first listed.
NCT01189396 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01189396 about?
NCT01189396 is a clinical study titled "Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006". The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses ...
What is the current status of trial NCT01189396?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2010-07. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01189396?
The interventions under investigation include: Placebo DPI (DRUG), A006 (DRUG), Proventil-HFA (DRUG).
Who is sponsoring clinical trial NCT01189396?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
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