A Relative Bioavailability Study of Propranolol HCl 160 mg Tablets Under Non-fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00864747
First received: March 18, 2009
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

The purpose of this study is to compare the relative bioavailability of Propranolol Hydrochloride Extended Release Capsules 160 mg (Actavis) with that of INDERAL® LA 160 mg Capsules (Wyeth Pharmaceuticals) following a single oral dose (1 x 160 mg) in healthy adult volunteers under non-fasting conditions.


Condition Intervention Phase
Healthy
Drug: Propranolol Hydrochloride Extended Release Capsules 160 mg
Drug: INDERAL® LA 160 mg Capsules, single dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of 160 mg Propranolol Hydrochloride Extended Release Capsules Under Non-Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: May 2005
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Propranolol Hydrochloride Extended Release Capsules 160 mg, single dose
Drug: Propranolol Hydrochloride Extended Release Capsules 160 mg
A: Experimental Subjects received Actavis formulated products under non-fasting conditions
Other Name: Propranolol
Active Comparator: B
INDERAL® LA 160 mg Capsules, single dose
Drug: INDERAL® LA 160 mg Capsules, single dose
B: Active comparator Subjects received Wyeth Pharmaceuticals formulated products non-under fasting conditions
Other Name: Propranolol

Detailed Description:

Study Type: Interventional Study Design: Randomized, single dose, two-way crossover study under non-fasting conditions

Official Title: A Relative Bioavailability Study of 160 mg Propranolol Hydrochloride Extended Release Capsules Under Non-Fasting Conditions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Volunteers who have been informed of the nature of the study and agree to read, review and sign the informed consent document prior to Period I dosing.
  2. Volunteers who have completed the screening process within 28 days prior to Period I dosing.
  3. Volunteers who are healthy adult men and women 18 to 50 years of age, inclusive, at the time of dosing.
  4. Volunteers who have a body mass index (BMI) between 18-32 kg/m2, inclusive, and weigh at least 110 lbs.
  5. Volunteers who are healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the normal range that might be considered clinically relevant by the study physician and investigator will be evaluated for individual cases, documented in study files, and agreed upon by both the study physician and investigator prior to enrolling the volunteer in this study and for continued enrollment.
  6. Volunteers who have a negative urine drug screen.
  7. Female volunteers must have a negative pregnancy screen.
  8. Female volunteers practicing an acceptable method of birth control as judged by the investigator(s), such as condom with spermicide, diaphragm with spermicide, intrauterine device (IUD), or abstinence throughout the duration of the study; or of postmenopausal (no menses) status for at least 1 year; or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

  1. Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing.
  2. Volunteers who report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
  3. Volunteers whose clinical laboratory test values outside the accepted reference range and when confirmed on re-examination is deemed to be clinically significant.
  4. Volunteers who demonstrate a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
  5. Volunteers who report a history of allergic response(s) to propranolol or related drugs.
  6. Volunteers who report the use of any systemic prescription medication in the 14 days prior to Period I dosing.
  7. Volunteers who report the use of any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
  8. Volunteers who report a history of clinically significant allergies including drug allergies.
  9. Volunteers who report a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
  10. Volunteers who report a history of drug or alcohol addiction or abuse within the past year.
  11. Volunteers who demonstrate a positive drug abuse screen for this study prior to Period I dose administration.
  12. Volunteers who currently use tobacco products.
  13. Volunteers who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
  14. Volunteers who report donating plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
  15. Volunteers who demonstrate a positive pregnancy screen (females only).
  16. Volunteers who are currently pregnant or breastfeeding (females only).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864747

Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58102
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: James D. Carlson,, Pharm.D, PRACS Institute, Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00864747     History of Changes
Other Study ID Numbers: R05-1384
Study First Received: March 18, 2009
Last Updated: August 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Bioequivalence
Propranolol
Healthy subjects

Additional relevant MeSH terms:
Propranolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents

ClinicalTrials.gov processed this record on July 24, 2014