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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649779 |
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 fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: albuterol sulfate extended-release 8 mg tablets Drug: VoSpire™ ER 8 mg tablets |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Fasting 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 8 mg tablets
|
Drug: albuterol sulfate extended-release 8 mg tablets
8mg, single dose fasting
|
|
2: Active Comparator
VoSpire™ ER 8 mg tablets
|
Drug: VoSpire™ ER 8 mg tablets
8mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
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-0516 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00649779 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
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 |