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NCT02271334 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers
A Phase 2 study, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT02271334: Completed Phase 2 study, sponsored by Amphastar Pharmaceuticals.
NCT02271334 is a Phase 2 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02271334, a Phase 2 study, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the pharmacokinetics (PK) and safety profiles of A006, an Albuterol dry powder inhaler (DPI), following a single dose of 110 mcg (T1) or 220 mcg (T2), in healthy male and female adult volunteers.
Primary Outcome
Subject PK blood samples will be taken prior to dosing and at multiple time points, up to 8 hours after dosing during each treatment period. PK samples will be analyzed using a validated test method. Area under the curve of the drug concentration versus time curve (AUC\[0-t\]) for each treatment period will be calculated using the trapezoidal rule.
Interventions
- DRUG A006 DPI
- DRUG Proventil® MDI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
What the finished NCT02271334 record still lists
NCT02271334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which A006 DPI is the first listed.
NCT02271334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02271334 about?
NCT02271334 is a clinical study titled "Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers". The objective of this study is to evaluate the pharmacokinetics (PK) and safety profiles of A006, an Albuterol dry powder inhaler (DPI), following a single dose of 110 mcg (T1) or 220 mcg (T2), in healthy male and female adult volunteers.
What is the current status of trial NCT02271334?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2014-08. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02271334?
The interventions under investigation include: A006 DPI (DRUG), Proventil® MDI (DRUG).
Who is sponsoring clinical trial NCT02271334?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02271334's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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