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Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers

NCT02271334 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-04-19

No results posted yet for this 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.

Conditions

Interventions

DRUG

A006 DPI

Single dose 110 mcg, 1 inhalation

DRUG

A006 DPI

Single dose 220 mcg, 1 inhalation

DRUG

Proventil® MDI

Single dose 90 mcg, 1 inhalation

DRUG

Proventil® MDI

Single dose 90 mcg, 2 inhalations

Sponsors & Collaborators

  • Amphastar Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Safety Monitor · Amphastar Pharmeceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-10-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02271334 on ClinicalTrials.gov