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| Sponsored by: |
Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649987 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's albuterol sulfate extended-release 8 mg tablets to Pliva's VoSpire™ ER 8 mg tablets following a single, oral 8 mg (1 x 8 mg) dose administered under fed conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Albuterol Sulfate Extended-Release Tablets 8 mg Drug: VoSpire® ER Tablets 8 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Fed Bioequivalence Study of Albuterol Sulfate Extended-Release Tablets (8 mg; Mylan) and VoSpire® ER Tablets (8 mg; Pliva) in Healthy Volunteers |
| Enrollment: | 21 |
| Study Start Date: | September 2005 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Albuterol Sulfate Extended-Release Tablets 8 mg
|
Drug: Albuterol Sulfate Extended-Release Tablets 8 mg
8mg, single dose fed
|
|
2: Active Comparator
VoSpire® ER Tablets 8 mg
|
Drug: VoSpire® ER Tablets 8 mg
8mg, single dose fed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female.
Women must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapies are permitted in this study. Acceptable forms of contraception include the following:
Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
(1) postmenopausal with an absence of menses for at least one (1) year, or (2) bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or (3) total hysterectomy
Exclusion Criteria:
1. Institutionalized subjects will not be used. 2. Social Habits:
Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
4. Diseases:
Abnormal and clinically relevant ECG tracing. 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
8. Allergy or hypersensitivity to albuterol sulfate or any related products. 9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
Contacts and Locations| United States, North Dakota | |
| PRACS Institute, Ltd. | |
| Fargo, North Dakota, United States, 58104 | |
| Principal Investigator: | James Carlson, Pharm. D. | PRACS Institute Ltd. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | ALBU-0517 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649987 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Albuterol Anti-Asthmatic Agents |
Peripheral Nervous System Agents Healthy Bronchodilator Agents Adrenergic Agonists |
|
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists Albuterol Physiological Effects of Drugs Anti-Asthmatic Agents |
Reproductive Control Agents Pharmacologic Actions Adrenergic Agonists Tocolytic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |