Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fed Condition
Information source: IPCA Laboratories Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fed
Intervention: Bisoprolol Fumarate Tablet 10 mg (Drug); Bisoprolol (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: IPCA Laboratories Ltd. Official(s) and/or principal investigator(s): Dr. Rupesh Vala, M.B.B.S., Principal Investigator, Affiliation: Accutest Research Lab (I) Pvt. Ltd.
Summary
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence
between Test Product and the corresponding Reference Product under fed condition in normal,
healthy, adult human subjects.
Clinical Details
Official title: A Randomized, Open Label, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg of With Zebeta® 10 mg in Normal, Healthy, Adult, Human Subjects Under Fed Condition.
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: CmaxAUC
Detailed description:
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 fed 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 about 240 mL of water at ambient temperature in sitting
position.
The duration of the clinical phase was approximately 15 days including washout period of at
least 10 days between administrations of study drug in each study period.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
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 receiving the high-fat
and high-calorie breakfast 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.
Locations and Contacts
Accutest Research Lab (I) Pvt. Ltd., Ahmedabad, Gujarat, India
Additional Information
Starting date: August 2012
Last updated: December 6, 2012
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