NCT02271334

Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers

Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers (A Randomized, Double- or Evaluator-blinded, Single-dose, Four-arm, Crossover Pharmacokinetics (PK) Study in Healthy Adults)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Amphastar Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a randomized, double or evaluator-blinded, single dose, four-arm, crossover PK study in eighteen (18) healthy volunteers, both male and female adults, at 18-40 years of age. All candidates will be screened and only those who satisfy all enrollment criteria will be enrolled into this study. Each study subject will participate in a screening visit and four (4) study visits with one (1) randomized study treatment given in each visit. PK samples will be analyzed with an established LC/MS/MS method. An End-of-Study (EOS) safety evaluation will be conducted at the end of Study Visit-4.

Conditions

• Asthma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-10-01
• Completion: 2015-03-01
• First posted: 2014-10-22
• Last updated: 2017-04-19

Locations

1 site across 1 country: United States