- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864747
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
Status
Completed
Conditions
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:
- 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).
Exclusion Criteria:
- 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).
- 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:
|
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:
|
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R05-1384
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Propranolol Hydrochloride Extended Release Capsules 160 mg
-
Mylan Pharmaceuticals IncCompleted
-
Mylan Pharmaceuticals IncCompleted
-
Actavis Inc.Completed
-
Luye Pharma Group Ltd.Shandong Luye Pharmaceutical Co., Ltd.Completed
-
AstraZenecaWithdrawnHealthy Male Subjects | Pharmacokinetics | Safety | Food EffectUnited Kingdom
-
Dr. Reddy's Laboratories LimitedCompleted
-
TaiRx, Inc.CompletedAdvanced CancerTaiwan
-
AbbottNot yet recruiting
-
Reata, a wholly owned subsidiary of BiogenAbbVieCompletedMItochondrial MyopathiesUnited States, Denmark
-
Reata, a wholly owned subsidiary of BiogenAbbVie; Friedreich's Ataxia Research AllianceActive, not recruitingFriedreich AtaxiaUnited States, Australia, Austria, Italy, United Kingdom