A Relative Bioavailability Study of Propranolol Hydrochloride 160 mg Tablets Under Fasting Conditions

NCT00865215 | Completed Phase 1

• 1 other identifier: R05-1383
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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 fasting conditions.

Conditions

Healthy

Keywords

Bioequivalence; Propranolol; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  48 hours

Study Arms (2)

A

EXPERIMENTAL

Propranolol Hydrochloride Extended Release Capsules 160 mg, single dose

Drug: Propranolol Hydrochloride Extended Release Capsules 160 mg

B

ACTIVE COMPARATOR

INDERAL® LA 160 mg Capsules, single dose

Drug: INDERAL® LA 160 mg Capsules, single dose

Interventions

Propranolol Hydrochloride Extended Release Capsules 160 mg DRUG

A: Experimental Subjects received Actavis formulated products under fasting conditions

Also known as: Propranolol

A

INDERAL® LA 160 mg Capsules, single dose DRUG

B: Active comparator Subjects received Wyeth Pharmaceuticals formulated products under fasting conditions

Also known as: Propranolol

B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Volunteers who have completed the screening process within 28 days prior to Period I dosing.
• Volunteers who are healthy adult men and women 18 to 50 years of age, inclusive, at the time of dosing.
• Volunteers who have a body mass index (BMI) between 18-32 kg/m2, inclusive, and weigh at least 110 lbs.
• 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.
• Volunteers who have a negative urine drug screen.
• Female volunteers must have a negative pregnancy screen.
• 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).

You may not qualify if:

• Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing.
• 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).
• Volunteers whose clinical laboratory test values outside the accepted reference range and when confirmed on re-examination is deemed to be clinically significant.
• Volunteers who demonstrate a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
• Volunteers who report a history of allergic response(s) to propranolol or related drugs.
• Volunteers who report the use of any systemic prescription medication in the 14 days prior to Period I dosing.
• 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.
• Volunteers who report a history of clinically significant allergies including drug allergies.
• Volunteers who report a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
• Volunteers who report a history of drug or alcohol addiction or abuse within the past year.
• Volunteers who demonstrate a positive drug abuse screen for this study prior to Period I dose administration.
• Volunteers who currently use tobacco products.
• 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.
• 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.
• Volunteers who demonstrate a positive pregnancy screen (females only).

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58102, United States

Location

MeSH Terms

Interventions

Propranolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• James D. Carlson,, Pharm.D,

  PRACS Institute, Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 19, 2009
• Study Start: April 1, 2005
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: August 17, 2010

Record last verified: 2010-08

Locations

US (1)