Fasting Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg

• ClinicalTrials.gov Identifier: NCT00649779
• Recruitment Status: Completed
• First Posted: April 1, 2008
• Last Update Posted: April 1, 2008
• Sponsor: Mylan Pharmaceuticals
• Information provided by: Mylan Pharmaceuticals

Tracking Information

• First Submitted Date: March 30, 2008
• First Posted Date: April 1, 2008
• Last Update Posted Date: April 1, 2008
• Study Start Date: September 2005
• Actual Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 31, 2008): Bioequivalence [ Time Frame: Within 30 days ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Fasting Study of Albuterol Sulfate Extended-Release Tablets 8 mg and VoSpire® ER Tablets 8 mg
• 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label)
• Condition: Healthy

Intervention

• Drug: albuterol sulfate extended-release 8 mg tablets
  8mg, single dose fasting
• Drug: VoSpire™ ER 8 mg tablets
  8mg, single dose fasting

Study Arms

• Experimental: 1
  albuterol sulfate extended-release 8 mg tablets
  Intervention: Drug: albuterol sulfate extended-release 8 mg tablets
• Active Comparator: 2
  VoSpire™ ER 8 mg tablets
  Intervention: Drug: VoSpire™ ER 8 mg tablets

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 31, 2008): 21
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2005
• Actual Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Age; 18 years and older.

2. Sex; Male and/or non-pregnant, non-lactating female.

   1. Women of childbearing potential must have a negative serum (Beta HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, the HCG pregnancy test should be given within 48 hours prior to dosing for each study period. An additional serum (Beta HCG) pregnancy test will be performed upon completion of the study.

   2. 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

      1. intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
      2. barrier methods containing or used in conjunction with a spermicidal agent, or
      3. surgical sterilization

   3. 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
   4. During the course of the study, from study screen until study exit - including the washout period, all men and women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive method. This advice should be documented in the informed consent form.
3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all subjects within 15% of their Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, Hepatitis B and Hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 21 days of the initial dose of study medication.

Exclusion Criteria:

1. Institutionalized subjects will not be used.

2. Social Habits:

   1. Use of any tobacco-containing products within 1 year of the start of the study.
   2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
   3. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
   4. Any recent, significant change in dietary or exercise habits.
   5. A positive test for any drug included in the urine drug screen.
   6. History of drug and/or alcohol abuse.

3. Medications:

   1. Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
   2. Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing.
   3. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.

4. Diseases:

   1. History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
   2. Acute illness at the time of either the pre-study medical evaluation or dosing.
   3. A positive HIV, Hepatitis B, or Hepatitis C test.

5. Abnormal and clinically significant laboratory test results:

   1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
   2. 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00649779
• Other Study ID Numbers: ALBU-0516
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc.
• Study Sponsor: Mylan Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Principal Investigator: James Carlson, Pharm. D.; PRACS Institute Ltd.

• PRS Account: Mylan Pharmaceuticals
• Verification Date: March 2008