Bioequivalence Study of Bisoprolol Fumarate Tablet 10 mg Under Fasting Condition

NCT01741623 | Completed Phase 1 DMC

• 1 other identifier: Ipca/ARL-12/147
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 fasting condition in normal, healthy, adult human subjects.

Conditions

Fasting

Outcome Measures

Primary Outcomes (2)

• Cmax

  pre-dose, 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose

  3 months

• AUC

  Pre-dose and at 00.50, 01.00, 01.50, 02.00, 02.33, 02.67, 03.00, 03.33, 03.67, 04.00, 04.50, 05.00, 06.00, 07.00, 08.00, 10.00, 12.00, 16.00, 20.00, 24.00, 48.00 and 72.00 hours post-dose.

  3 months

Study Arms (2)

Bisoprolol Fumarate Tablet 10 mg

EXPERIMENTAL

Bisoprolol Fumarate Tablet 10 mg of M/s Ipca Laboratories Limited, India

Drug: Bisoprolol Fumarate Tablet 10 mg

Zebeta®

ACTIVE COMPARATOR

Zebeta® (Bisoprolol Fumarate) Tablets 10 mg of Duramed Pharmaceuticals Inc., USA

Drug: Bisoprolol

Interventions

Bisoprolol Fumarate Tablet 10 mg DRUG

10 mg tablet once a day

Also known as: Test Product

Bisoprolol Fumarate Tablet 10 mg

Bisoprolol DRUG

10 mg tablet once a day

Also known as: Zebeta®

Zebeta®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and Non-pregnant female human subjects, age in the range of 18 - 45 years (both inclusive).
• Body weight within ± 15% of ideal weight as related to height and body frame according to Life Insurance Corporation (LIC) Chart.
• Subjects with normal findings as determined by baseline history, physical examination and vital signs (blood pressure, pulse rate, respiration rate and oral temperature).
• 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).
• Willingness to follow the protocol requirements as evidenced by written informed consent.
• Subject willing to give written informed consent.
• 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.
• No history of drug abuse in the past one year.
• 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.
• was surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).

You may not qualify if:

• Known history of hypersensitivity to Bisoprolol Fumarate, or related drugs.
• Requiring medication for any ailment having enzyme-modifying activity in the previous 28 days, prior to dosing day.
• Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, blood-forming organs etc.
• History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric diseases and bleeding tendency.
• Participation in a clinical drug study or bioequivalence study within 90 days prior to present study.
• History of malignancy or other serious diseases.
• 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.
• Any contraindication to blood sampling or difficulty in accessibility of veins.
• 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.
• 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.
• Blood donation within 90 days prior to the commencement of the study.
• Subjects with positive HIV tests or Hepatitis-B or Hepatitis-C tests.
• Found positive in breath alcohol test done before check-in for each study period.
• Found positive in urine test for drugs of abuse done before check-in for each study period.
• Refusal to abstain from consumption of tobacco products 24.00 hours prior to dosing until the last blood sample collection of last study period.

Sponsors & Collaborators

• IPCA Laboratories Ltd.: lead

Study Sites (1)

Accutest Research Lab (I) Pvt. Ltd.

Ahmedabad, Gujarat, India

Location

MeSH Terms

Conditions

Fasting

Interventions

Bisoprolol

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Dr. Rupesh Vala, M.B.B.S.

  Accutest Research Lab (I) Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2012
• First Posted: December 5, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 5, 2012

Record last verified: 2012-12

Locations

IN (1)