Bioavailability Study of Propranolol Under Fasting Conditions

NCT00653120 | Completed Phase 2

• 1 other identifier: 40451
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the single-dose bioavailability of Propranolol 160 Mg ER capsules with Inderal-La

Conditions

To Determine Bioequivalence Under Fasting Conditions

Keywords

Bioequivalence, Propranolol ER capsules, fasting

Outcome Measures

Primary Outcomes (1)

• Rate and Extend of Absorption

  24 Hours

Study Arms (2)

A

EXPERIMENTAL

Subjects received Par Products under fasting conditions

Drug: Propranolol

B

ACTIVE COMPARATOR

Subjects received Wyeth Pharmaceuticals product under fasting conditions

Drug: Inderal-LA

Interventions

Propranolol DRUG

ER capsules, 160 mg, single-dose

Also known as: Inderal-LA

A

Inderal-LA DRUG

ER capsules, 160 mg, single-dose

Also known as: Propranolol

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects enrolled in the study will be members of the community at large. The Recruitment advertisements may use various media types (E.g. ratio, newspapers, SFBC Anapharm Website, SFBC Anapharm volunteer's database). Subjects must meet all the following criteria in order to be included in the study.
• Male and female, non-smoker, 18 years of age and older
• Capable of consent
• BMI ≥ 19.0 and \> 30.0 kg/ m2.

You may not qualify if:

• Subjects to whom any of the following applies will be excluded from the study.
• Clinically significant illness within 4 weeks prior to the administration of the study medication
• Clinically significant surgery within 4 weeks prior to the administration of the study medication.
• Any clinically significant abnormality found during medical screening.
• Any reason which, in the opinion of the Medical Sub- Investigator, would prevent the subject from participating in the study.
• Abnormal laboratory tests judged clinically significant.
• Positive testing for hepatitis B, hepatitis C, or HIV at screening.
• ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 or over 140 mmHg, diastolic blood pressure lower than 60 or over 90 mmHg, or heart rate less than 60 or over 100 bpm) at screening.
• History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
• Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week \[ 1 Unit = 150mL of wine, 360 mL of beer, or 45mL of 40% alcohol\])
• Use of soft drugs ( such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\] and crack) within 1 year prior to the screening visit or positive urine drug at screening.
• History of allergic reactions to heparin, propranolol, or other related drugs.
• Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin,glucocorticoids , omerprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
• Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
• Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known as interface with the absorption, distribution, metabolism, or excretion of the drug.

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• SFBC Anapharm: collaborator

Study Sites (1)

SFBC Anapharm

Sainte-Foy, Quebec, G1V2K8, Canada

Location

MeSH Terms

Conditions

Fasting

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

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

• Denis Audet

  SFBC Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: May 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: April 4, 2008

Record last verified: 2008-04

Locations

CA (1)