An open-label, balanced, randomized, two treatment, two sequence, two period, two way crossover, single oral dose bioequivalence study of fixed-dose combination of Bisoprolol Fumarate 5 mg Tablets + Perindopril arginine 10 mg Tablets of Servier India Private Limited and Reference product : EU approved / marketed : Concor (Bisoprolol Fumarate) 5 mg film-coated tablets of Merck Kft., Hungary and Coversyl (Perindopril arginine) 10 mg film-coated tablets of Les Laboratoires Servier 50 rue Carnot 92284 Suresnes cedex France, in normal, healthy, adult, human subjects under fasting conditions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- To assess bioequivalence of the test product in comparison
研究概览
简要总结
Servier India Private Limited has developed a fixed dose combination tablet containing Bisoprolol 5mg and Perindopril arginine 5 mg tablets and Bisoprolol 5 mg and Perindopril arginine 10 mg tablets as a bi-layered tablet.
Therefore, Servier India is proposing to conduct An open-label, balanced, randomized, two treatment, two sequence, two period, two way crossover, single oral dose bioequivalence study of fixed-dose combination of Bisoprolol Fumarate 5 mg Tablets + Perindopril arginine 10 mg Tablets of Servier India Private Limited and Reference product : EU approved / marketed : Concor (Bisoprolol Fumarate) 5 mg film-coated tablets of Merck Kft., Hungary and Coversyl (Perindopril arginine) 10 mg film-coated tablets of Les Laboratoires Servier 50 rue Carnot 92284 Suresnes cedex France, in normal, healthy, adult, human subjects under fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age; Body mass index in the range of 18.50 29.99 kg/m2 (both inclusive) Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs measurements and physical examination at the time of screening as well as check-in of each study period; Normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis; Normal or clinically non-significant 12-lead ECG recording; Non-smokers or subjects who have no history of smoking for the last one year prior to check-in; Willing to abstain from chewing any tobacco containing products at least 72.00 hours prior to check-in until last sample collection in each study period; Willing to abstain from alcohol or alcoholic products at least 24.00 hours prior to check-in until last sample collection in each study period; Willing to abstain from xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks), at least 48.00 hours prior to check-in until last sample collection in each study period; Willing to abstain from grapefruit or its juice at least 72.00 hours prior to check-in until last sample collection in each study period; For female subjects: Negative urine pregnancy test during screening and negative serum -hCG test at the time of check-in of each study period; Female subjects with child bearing potential or those within their first two years of onset of menopausal syndrome willing to either abstain from sexual intercourse, or should use of acceptable birth control methods for at least 15 days before 1st check-in till 15 days post last-dose / entire study period.
- •[Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed)].
排除标准
- •Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract and of blood forming organs; Significant history or current evidence of malignancy or chronic.
- •infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction; Any major illness or hospitalized within 90 days prior to the first check-in; Requiring medication for any ailment having enzyme-modifying activity within one month prior to first check-in and throughout the study; Use of any depot injection or an implant of any drug within 3 months prior to first check-in and throughout the study; Use of any prescribed medication (including herbal medicines and vitamin supplements) or OTC products within 30 days prior to first check-in and throughout the study; History or presence of significant gastric and/or duodenal ulceration; Difficulty in swallowing tablets or capsules; Use of any recreational drug or history of drug addiction; Participated in any clinical investigation requiring repeated blood sampling or have donated blood in past 90 days prior to first check-in; Positive breath alcohol and urine drug of abuse tests during check-in of each study period; Reactive test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies; Lactating or nursing female subjects; Female subjects using hormonal contraceptive (either oral/implants); History of allergy or hypersensitivity intolerance to Bisoprolol Fumarate and Perindopril Arginine or its formulation excipients which, in the opinion of a clinical investigator, would compromise the safety of the subject or the study; History of difficulty in accessibility of veins in arms.
结局指标
主要结局
To assess bioequivalence of the test product in comparison
时间窗: For Bisoprolol and Perindoprilat 0.000(within 2.000 hours prior to dosing) 0.167 0.334 0.500 0.750 1.000 1.334 1.667 2.000 2.334 2.667 3.000 3.334 3.667 4.000 4.500 5.000 6.000 8.000 12.000 16.000 24.000 36.000 48.000 and 72.000 hrs post dose. | For Perindopril 0.000 (within 2.000 hrs prior to dosing) 0.167 0.334 0.500 0.750 1.000 1.334 1.667 2.000 2.334 2.667 3.000 3.334 3.667 4.000 4.500 5.000 6.000 and 8.000 hrs post dose. A washout period of at least 14 days.
with the reference product
时间窗: For Bisoprolol and Perindoprilat 0.000(within 2.000 hours prior to dosing) 0.167 0.334 0.500 0.750 1.000 1.334 1.667 2.000 2.334 2.667 3.000 3.334 3.667 4.000 4.500 5.000 6.000 8.000 12.000 16.000 24.000 36.000 48.000 and 72.000 hrs post dose. | For Perindopril 0.000 (within 2.000 hrs prior to dosing) 0.167 0.334 0.500 0.750 1.000 1.334 1.667 2.000 2.334 2.667 3.000 3.334 3.667 4.000 4.500 5.000 6.000 and 8.000 hrs post dose. A washout period of at least 14 days.
次要结局
- To assess safety and tolerability of the Test Product in comparison with the EU approved Reference Product.(For Bisoprolol and Perindoprilat 0.000(within 2.000 hours prior to dosing) 0.167 0.334 0.500 0.750 1.000 1.334 1.667 2.000 2.334 2.667 3.000 3.334 3.667 4.000 4.500 5.000 6.000 8.000 12.000 16.000 24.000 36.000 48.000 and 72.000 hrs post dose.)
研究者
Dr Raviraj Jagdhani
Raptim Research Pvt Ltd