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

August 13, 2010 updated by: Actavis Inc.

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

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.

Study Overview

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • PRACS Institute, Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Propranolol Hydrochloride Extended Release Capsules 160 mg, single dose
A: Experimental Subjects received Actavis formulated products under non-fasting conditions
Other Names:
  • Propranolol
Active Comparator: B
INDERAL® LA 160 mg Capsules, single dose
B: Active comparator Subjects received Wyeth Pharmaceuticals formulated products non-under fasting conditions
Other Names:
  • Propranolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate and Extend of Absorption
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

March 18, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Estimate)

August 17, 2010

Last Update Submitted That Met QC Criteria

August 13, 2010

Last Verified

August 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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