NCT00865215CompletedPhase 1
A Relative Bioavailability Study of 160 mg Propranolol Hydrochloride Extended Release Capsules Under Fasting Conditions
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Actavis Inc.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Rate and Extend of Absorption
Study Overview
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.
Detailed Description
Study Type: Interventional Study Design: Randomized, single dose, two-way crossover study under fasting conditions
Official Title: A Relative Bioavailability Study of 160 mg Propranolol Hydrochloride Extended Release Capsules Under Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
A
Experimental
Propranolol Hydrochloride Extended Release Capsules 160 mg, single dose
Intervention: Propranolol Hydrochloride Extended Release Capsules 160 mg (Drug)
B
Active Comparator
INDERAL® LA 160 mg Capsules, single dose
Intervention: INDERAL® LA 160 mg Capsules, single dose (Drug)
Outcomes
Primary Outcomes
Rate and Extend of Absorption
Time Frame: 48 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 2
a Prospective Cohort Study for Propranolol Treatment in Retinopathy of PrematurityRetinopathy of PrematurityNCT03038295Guangdong Women and Children Hospital100
Completed
Phase 4
The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric HemangiomaHemangiomaNCT01908972Seoul National University Hospital34
Recruiting
Phase 1
Evaluating the effect of oral Propranolol in preventing the progression of retinopathy of prematurityretinopathy of prematurity.Retinopathy of prematurity, unspecified, bilateralH35.103IRCT20230717058817N1Ardabil University of Medical Sciences66
Completed
Phase 2
Safety and Efficacy of Propranolol in Newborns With Retinopathy of PrematurityRetinopathy of PrematurityNCT01079715Azienda Ospedaliero, Universitaria Meyer52
Recruiting
Phase 1
A phase 2 trial on propranolol in combination with pembrolizumab in advanced Angiosarcoma and Undifferentiated Pleomorphic SarcomaAdvanced Angiosarcoma and Undifferentiated Pleomorphic SarcomaMedDRA version: 21.1Level: PTClassification code: 10002476Term: Angiosarcoma Class: 100000004864MedDRA version: 25.1Level: LLTClassification code: 10087873Term: Undifferentiated pleomorphic sarcoma Class: 100000004848CTIS2024-513727-16-00Region Hovedstaden80