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 Fasting Condition.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
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.
详细描述
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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
- •History of problem in swallowing Tablet(s).
- •Female subject, demonstrating positive urine pregnancy test at the time of screening.
- •Female subject, demonstrating positive Serum (ß) Beta- hCG (Human Chorionic Gonadotropin) test before check-in for each study period.
- •Female subject, currently breast feeding or lactating.
- •Female subjects not willing to use acceptable method of contraception from the date of screening until the completion of the study.
研究组 & 干预措施
Bisoprolol Fumarate Tablet 10 mg
Bisoprolol Fumarate Tablet 10 mg of M/s Ipca Laboratories Limited, India
干预措施: Bisoprolol Fumarate Tablet 10 mg (Drug)
Zebeta®
Zebeta® (Bisoprolol Fumarate) Tablets 10 mg of Duramed Pharmaceuticals Inc., USA
干预措施: Bisoprolol (Drug)
结局指标
主要结局
Cmax
时间窗: 3 months
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
AUC
时间窗: 3 months
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.
次要结局
未报告次要终点