To compare the single-dose bioavailability of Propranolol 160 Mg ER capsules with Inderal-La
To compare the single - dose bioavailability of Par Propranolol 160 Mg ER capsules with Wyeth
Minimum age: 18 Years.
Maximum age: N/A.
- 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.
- 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
- Clinically significant surgery within 4 weeks prior to the administration of the study
- 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
- 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.
- Any clinically significant history or presence of clinically significant neurological,
endocrinal, cardiovascular, pulmonary, hematologic, psychiatric, or metabolic
- Use of prescription medication within 14 days prior to administration of a study
medication or over the counter products (including natural food supplements, vitamins,
garlic as a supplement) within 7 days prior to administration of study medication,
except for topical products without systemic absorption and hormonal contraceptive.
- Difficulty to swallow study medication.
- Use of any tobacco products in the 6 months proceeding drug administration.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the
Medical Sub- Investigator, could contraindicate the subject's participation in this
- A depot injection or an implant of any drug (other than contraceptives) within 3
months prior to administration of study medication.
- Donation of plasma (500 Ml) within 7 days to drug administration. Donation or loss of
whole blood (excluding the volume of blood drawn during the screening procedures of
this study) prior to administration of the study medication as follows.
- 50mL to 300mL of whole blood within 30 days, 301 mL to 500 ml of whole blood within
45days or more than 500 mL of whole blood within 56 days prior to drug
- History bronchial asthma and bronchospastic diseases.
- History of known presence of cardiogenic shock, sinus bradycardia, Wolff-Parkinson
White Syndrome, congestive heart failure or angina.
- Clinically significant history of diabetes.
- Clinically significant history of hyperthyroidism.
- Breast- feeding subject.
- Positive urine pregnancy test at screening.
- Female subjects of childbearing potential having unprotected sexual intercourse with
any non- sterile male partner (i. e. male who ahs not been sterilized by vasectomy for
al least 6 months) within 14 days prior to study drug administration. Acceptable
methods of contraception:
- Intra-uterine contraceptive device (place al least 4 weeks prior to study drug
- Condom or diaphragm. + spermicide
- Hormonal contraceptives (starting al least 4 weeks prior to study administration)