TCTR20230620003已完成1 期
Bioequivalence Study of Simvastatin Ezetimibe 20/10 mg Tablet: A randomised, open label, reference replicate study on healthy volunteer in fasting condition
Duopharma Biotech Berhad0 个研究点目标入组 52 人开始时间: 2023年6月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
The 90% confidence interval of Cmax and AUC0-t for Ezetimibe, Total Ezetimibe and Simvastatin were within the acceptable limit. The test product is bioequivalent to the reference product.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1. Normal healthy human between 18-45 years (both ages inclusive) of age
- •2. Volunteer provided written inform consent and are willing to participate in the study
- •3. Volunteer having body mass index of 18.50-30.00 kg/m3 (both inclusive)
- •4. No evidence of underlying disease during pre-study screening, medical history, physical examination and laboratory investigations performed within 21 days prior to commencement of the study
- •5. Pre-study screening laboratory test are either normal or within acceptable limit or are considered by the investigator to be no clinical significance with respect to participation in the study.
- •6. Negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C, and RPR.
- •7. Non-smoker, non-tobacco (ina any form) users, non alcoholic with negative test for alcohol (in breath), negative urine drug of abuse test
- •8. 12 lead ECG recording either normal or within acceptable limits or as considered by investigator to be non clinical significance with respect to his/ her participation in the study
- •9. Normal or clinically non-significant chest x-ray (PA) taken within 06 months before the day of dosing
- •10. Available for the entire study period and capable of understanding instructions and communicating with the investigators and clinical study facility staff.
- •11. Female volunteers who have negative result in urine pregnancy test during screening and Beta hCG-test at the time of check-in
- •12. Female with child bearing potential must agree to use an acceptable method of contraception at least 02 days prior to dosing of IP, during the study and for 14 days following their last dose of IP
- •13. Male volunteers and/ or female volunteer's partner must agree to use condoms, vasectomy or spermicide in addition to female contraception for additional protection against conception throughout the study
排除标准
- •1. Known allergy to Simvastatin and Ezetimibe or any component of the formulation and to any other related drug.
- •2. History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease
- •3. Female volunteers who are nursing mothers/ lactating women or are found positive in beta hCG test
- •4. History/ presence of significant alcohol dependence (abuse) or drug abuse within the past 1 year, current alcohol abuse (.5 units/ week, 1 unit= 10 mL or 8 g of pure alcohol) or suspected abuse
- •5. History of alcohol or drug abuse
- •6. History of smoking even single cigarette, bidis or any other form
- •7. History/ presence of asthma
- •8. History/ presence of urticaria or other allergic-type reactions after taking any medication
- •9. History/ presence of clinically significant illness within 04 weeks before the start of study
- •10. History/presence of significant hypersensitivity to heparin
- •11. History of clinically relevant allergy (except for untreated asymptomatic, seasonal allergies at the time of dosing) or any allergy reaction to any drugs
- •12. Who is schedule for surgery any time during study or within 14 days after study completion
- •13. History of difficulty in donating blood
- •14. Who has unstable veins for repeated venipuncture
- •15. Who is participating in any other clinical or bioequivalence study or otherwise would have donated in excess of 350 ml of blood in last 90 days
- •16. Who has taken prescription medication or OTC products (including vitamins and natural products) within 14 days prior to dosing of IP in Period 1, including topical medication.
- •17. Who was hospitalized within 28 days prior to administration of the study medication
- •18. History of difficulty in swallowing
- •19. Evidence of skin lesions on forearm of signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial
- •20. Who has systolic blood pressure less than 90 mm of the Hg or more than 140 mm of Hg. Minor deviations (2-4 mm Hg) at check in may be acceptable at the discretion of the investigator
- •21. Who has diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 m m of Hg) at check-in may be acceptable at the discretion of investigator
研究者
相似试验
已完成
3 期
A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)Coronary DiseaseNCT00551447Organon and Co616
进行中（未招募）
不适用
The effect of Ezetimibe 10 mg, Simvastatin 20 mg and the Combination of Simvastatin 20 mg plus 10 mg Ezetimibe on LDL-Subfractions in patients with Type 2 Diabetes (Die Wirkung einer Monotherapie mit Ezetimib 10 mg vs. Monotherapie mit Simvastatin 20 mg vs. Kombinationsbehandlung mit Ezetimib 10 mg und Simvastatin 20 mg auf die LDL-Subfraktionen bei Patienten mit Typ II Diabetes)well controlled type II diabetes mellitus (HbA1c < 8.0 %) with a preponderance of atherogenic small, dense LDL (LDL-5 and LDL-6 > 25 mg/dL)MedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusEUCTR2006-005906-30-DEniversitätsklinikum Freiburg, Abteilung klinische Chemie60
尚未招募
1 期
Bioequivalence Study of 10 mg Ezetimibe Tablet Preparations in Healthy Thai VolunteersBioequivalence study in healthy volunteersBioequivalenceEzetimibeTCTR20170719004Bio-innova and Synchron.Co.,Ltd40
已完成
4 期
Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)HypercholesterolaemiaAtherosclerosisNCT00653835Organon and Co153
招募中
不适用
Bioequivalence study of Rosuvamibe (rosuvastatin 20 mg/ezetimibe 10 mg fixed dose combination) tabletsEndocrine, nutritional and metabolic diseaseKCT0003310Yuhan60