Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fasting Condition

Launched by IPCA LABORATORIES LTD. · Dec 1, 2012

Keywords

ClinConnect Summary

Objective of this pivotal study was to assess the bioequivalence between Test Product: Bisoprolol Fumarate Tablet 10 mg of Ipca Laboratories Limited, India and the corresponding Reference Product: Zebeta® (Bisoprolol Fumarate) Tablets 10 mg of Duramed Pharmaceuticals Inc., USA under fasting condition in normal, healthy, adult, human subjects in a randomized crossover study.

The study was conducted with 24 healthy adult subjects. In each study period, a single 10 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and Non-pregnant female human subjects, age in the range of 18 - 45 years (both inclusive).
• • 2. Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
• • 3. Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).
• • 4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry, serology (HIV, Hepatitis B and Hepatitis C), urinalysis, 12 lead ECG and chest X-ray (chest X-ray if required).
• • 5. Willingness to follow the protocol requirements as evidenced by written informed consent.
• • 6. Subject willing to give written informed consent.
• • 7. Confirming and agreeing to, not using any prescription and over the counter medications including vitamins and minerals for 14 days prior to study and during the course of the study.
• • 8. No history of drug abuse in the past one year.
• • 9. Non-smokers and non-alcoholics.
• • 10. For female subject
• • was child bearing potential practicing acceptable method of birth control for the duration of the study as judged by Investigator such as Condom, Foams, Jellies, Diaphragm, Intrauterine device and Abstinence.
• • OR
• • was surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).
• Exclusion Criteria:
• • 1. Known history of hypersensitivity to Bisoprolol Fumarate, or related drugs.
• • 2. Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
• • 3. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
• • 4. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.
• • 5. Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.
• • 6. History of malignancy or other serious diseases.
• • 7. Refusal to abstain from food for at least 10.00 hours prior to study drug administration and for at least 04.00 hours post-dose, in each study period.
• • 8. Any contraindication to blood sampling or difficulty in accessibility of veins.
• • 9. Refusal to abstain from fluid for at least 01.00 hour prior to study drug administration and for at least 01.00 additional hour post-dose, in each study period except about 240 mL of water given during administration of study drug.
• • 10. Refusal to avoid the use of xanthine-containing food or beverages (chocolates, tea, coffee or cola drinks) or fruit juice/grapefruit juice and any alcoholic products for 48.00 hours prior to dosing until the last blood sample collection of last study period.
• • 11. Blood donation within 90 days prior to the commencement of the study.
• • 12. Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.
• • 13. Found positive in breath alcohol test done before check-in for each study period.
• • 14. Found positive in urine test for drugs of abuse done before check-in for each study period.
• • 15. Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing until the last blood sample collection of last study period.
• • 16. History of problem in swallowing Tablet(s).
• • 17. Female subject, demonstrating positive urine pregnancy test at the time of screening.
• • 18. Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.
• • 19. Female subject, currently breast feeding or lactating.
• • 20. Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study.