DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers

Information source: Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: A006 DPI (Drug); A006 DPI (Drug); Proventil® MDI (Drug); Proventil® MDI (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Amphastar Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Study Director, Study Director, Affiliation: Amphastar Pharmeceuticals, Inc.

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.

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Area Under the Curve of Drug Concentration versus Time (AUC[0-t])

Peak Plasma Concentration (C[max])

Time to Reach Peak Plasma Concentration (t[max])

Plasma Albuterol Concentrations at All Time Points

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.

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Generally healthy, male and female adults, 18-40 years of age at Screening;

- Having no clinically significant respiratory, cardiovascular and other systemic or

organic illnesses;

- Body weight ≥ 50 kg for men and ≥ 45 kg for women, and BMI within the range of 18. 5 -

30. 0 kg/m2 inclusive;

- Sitting blood pressure ≤ 135/90 mmHg;

- Demonstrating negative HIV, HBsAg and HCV tests, alcohol and nine panel urine drug

screen tests;

- Demonstrating proficiency in the use of DPI and MDI or able to be trained in the

proper use of these devices;

- Demonstrating Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training),

for at least 2 times consecutively, with a maximum of 5 attempts;

- Having no known hypersensitivity to any ingredients of A006 and Proventil® MDI

(Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid, or ethanol). (Subjects must be able to tolerate at least one teaspoon of milk);

- Women of child-bearing potential must be non-pregnant, non-lactating, and practicing

a clinically acceptable form of birth control; and

- Having properly consented and satisfied all other inclusion/exclusion criteria as

required for this protocol. Exclusion Criteria:

- A smoking history of ≥ 5 pack-years, or having smoked within 6 months prior to

Screening;

- Upper respiratory tract infections within 2 weeks, or lower respiratory tract

infection within 4 weeks, prior to Screening;

- Previous history of asthma or COPD;

- Any current or recent respiratory conditions that, per investigator discretion, might

significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases;

- Concurrent clinically significant cardiovascular, hematological, renal, neurologic,

hepatic, endocrine, psychiatric, malignant, or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study;

- ECG at Screening and Visit-1 baseline expressed any single or multiple premature

ventricular contractions (PVC);

- ECG at Screening and Visit-1 baseline with a QTc reading greater than 450ms;

- Use of prohibited drugs or failure to observe the drug washout restrictions; and

- Having been on other clinical drug/device studies or donated blood in the last 30

days prior to Screening.

Locations and Contacts

WCCT Global, LLC, Cypress, California 90630, United States
Additional Information

Related publications:

Lipworth BJ, Clark DJ. Lung delivery of salbutamol given by breath activated pressurized aerosol and dry powder inhaler devices. Pulm Pharmacol Ther. 1997 Aug;10(4):211-4.

Ahrens RC. The role of the MDI and DPI in pediatric patients: "Children are not just miniature adults". Respir Care. 2005 Oct;50(10):1323-8; discussion 1328-30. Review.

Goldstein DA, Tan YK, Soldin SJ. Pharmacokinetics and absolute bioavailability of salbutamol in healthy adult volunteers. Eur J Clin Pharmacol. 1987;32(6):631-4.

Hindle M, Newton DA, Chrystyn H. Dry powder inhalers are bioequivalent to metered-dose inhalers. A study using a new urinary albuterol (salbutamol) assay technique. Chest. 1995 Mar;107(3):629-33.

Starting date: August 2014
Last updated: April 6, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017