Journal article
Demonstration of In Vivo Bioequivalence of a Generic Albuterol Metered-Dose Inhaler to Ventolin
Chest, Vol.117(3), pp.714-721
03/2000
DOI: 10.1378/chest.117.3.714
PMID: 10712996
Abstract
To use histamine bronchoprovocation and bioassay statistical procedures to evaluate the in vivo bioequivalence of a generic albuterol metered-dose inhaler (MDI).
A randomized, double-blind, balanced, crossover design was used to determine the potency of each generic albuterol MDI actuation relative to Ventolin (Glaxo Wellcome; Research Triangle Park, NC) administration. One treatment was administered on each of 4 study days. A histamine bronchoprovocation procedure was initiated 1.25 h before and 15 min after administration of the study treatment.
Twenty-four nonsmoking subjects with mild-to-moderate asthma were studied (18 to 65 years of age; FEV1, > 60% of predicted; and provocative concentration of histamine causing a 20% fall in FEV1[ PC20], ≤ 8 mg/mL at screening).
One and four actuations (90 and 360 μg, respectively) of the generic MDI and of Ventolin MDI. Placebo inhalers were used to maintain blinding of inhaler and doses.
The primary outcome variable was histamine PC20 measured after study treatment administration. A significant dose-effect relationship was present (p < 0.0001). Deviation from parallelism of the generic and Ventolin dose-response curves (p = 0.95) and differences in overall mean response between the two formulations (p = 0.68) were not significant. Using Finney 2 × 2 bioassay statistical procedures, we estimated that one actuation of the generic albuterol MDI was equivalent to 1.01 puffs of Ventolin (90% confidence interval, 0.69 to 1.50).
The generic albuterol MDI delivers a quantity of albuterol to the β2-receptor site in the lung that is the bioequivalent to Ventolin. Further, this study reinforces the validity of this statistical methodology for determining in vivo bioequivalence.
Details
- Title: Subtitle
- Demonstration of In Vivo Bioequivalence of a Generic Albuterol Metered-Dose Inhaler to Ventolin
- Creators
- Barbara A. Stewart - Healthcare Professional Associates, Amarillo, TXRichard C. Ahrens - University of IowaSteve Carrier - Norton HealthcareMichael Frosolono - Norton HealthcareCheri Lux - University of IowaSeung-Ho Han - University of IowaGary Milavetz - University of Iowa
- Resource Type
- Journal article
- Publication Details
- Chest, Vol.117(3), pp.714-721
- Publisher
- Elsevier Inc
- DOI
- 10.1378/chest.117.3.714
- PMID
- 10712996
- ISSN
- 0012-3692
- eISSN
- 1931-3543
- Language
- English
- Date published
- 03/2000
- Academic Unit
- Pharmacy; Stead Family Department of Pediatrics; Pharmacy Practice and Science
- Record Identifier
- 9984366040402771
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