跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/TCTR20200302001
TCTR20200302001尚未招募1 期

A Randomized, Open Label, Two Treatment, Four period, Two Sequence, Full Replicate, Single Dose, Crossover Bioequivalence Study of Entacapone GPO (200 mg) (Entacapone 200 mg Tablets) of The Government Pharmaceutical Organization, with Comtan (Entacap

The Government Pharmaceutical Organization0 个研究点目标入组 36 人开始时间: 2020年3月2日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
1 期
状态
尚未招募
入组人数
36
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

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. Male and non-pregnant female human subjects, age in the range of 18 †45 years
  • •both inclusive.
  • •2. Body Mass Index between 18-30 Kg / m2 extremes included.
  • •3. Subjects with normal findings as determined by baseline history, physical
  • •examination and vital sign examination (blood pressure, pulse rate, respiration
  • •rate and body temperature).
  • •4. Subjects with clinically acceptable findings as determined by haematology,
  • •biochemistry, urinalysis, 12 lead ECG and chest X-ray (if done).
  • •5. Willingness to follow the protocol requirements especially abstaining from
  • •xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or
  • •grapefruit juice, any alcoholic products, the use of cigarettes and the use of
  • •tobacco products for 72.00 hours prior to dosing until after the last blood sample
  • •collection in each study period and adherence to food, fluid and posture
  • •restrictions.
  • •6. No history of significant alcoholism. A recent history of harmful use of alcohol
  • •(less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per
  • •week for men and more than 7 standard drinks per week for women (A standard
  • •drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled
  • •spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic
  • •products within 48 hours prior to dosing in Period-I.
  • •7. No history of drug abuse (morphine, cannabinoids, amphetamine, cocaine,
  • •benzodiazepines and barbiturates) for the last one month and other illegal drugs
  • •(Appendix B) for the last 06 months.
  • •8. Non-smokers, ex-smokers and moderate smokers will be included. “Moderate
  • •smokers are defined as someone smoking 10 cigarettes or less per day,
  • •ex-smokers are someone who completely stopped smoking for at least 3 months.”
  • •9. For female: Subject is 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 and Abstinence.
  • •Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy or
  • •hysterectomy has been performed on the subject).

排除标准

  • •1. Known history of hypersensitivity to Entacapone or related drugs or peanut or
  • •soya or any of excipients.
  • •2. Requiring medication for any ailment having enzyme-modifying activity in the
  • •previous 28 days, prior to dosing day.
  • •3. Subjects who have taken prescription medications or over-the-counter products
  • •(including vitamins and minerals) within 14 days prior to administration of IMP.
  • •4. Any medical or surgical conditions, which might significantly interfere with the
  • •functioning of gastrointestinal tract, bloodâ€forming organs etc.
  • •5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological,
  • •metabolic, haematological, gastrointestinal, endocrine, immunological or
  • •psychiatric diseases.
  • •6. Participation in a clinical drug study or bioequivalence study 90 days prior to
  • •period I dosing of the present study.
  • •7. History of malignancy or other serious diseases.
  • •8. Blood donation 90 days prior to period I dosing of the present study.
  • •9. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
  • •10. Found positive in breath alcohol test.
  • •11. Found positive in urine test for drug abuse.
  • •12. History of problem in swallowing.
  • •13. Any contraindication to blood sampling.
  • •14. Subjects requiring mental alertness and motor coordination, such as driving a
  • •motor vehicle or operating machine?
  • •15. History or presence of seizure or psychiatric disorder.
  • •16. An unusual diet, for whatever reason (for example, fasting, high potassium or
  • •low-sodium), for four weeks prior to receiving the study drug in period I. In any
  • •such case subject selection will be at the discretion of the Principal Investigator.
  • •17. Subjects with Orthostatic hypotension i.e.,-Sitting blood pressure less than 100/60
  • •mm of Hg, or pulse rate less than 60 per minute or more than 100 beats per minute
  • •18. Female subjects found positive serum (β) Beta- hCG (Human Chorionic
  • •Gonadotropin) test.
  • •19. Lactating women (currently breast feeding).
  • •20. Female subjects not confirming to using birth control measures, from the date of
  • •screening until the completion of the study. Abstinence, barrier methods (condom,
  • •diaphragm, etc.) are acceptable.
  • •21. Use of hormonal contraceptives either oral or implants.

研究者

相似试验

尚未招募
不适用
Bioequivalence study of Dapoxetine 30mg tablet of Alborz Darou Pharm Co., IRAPremature ejaculation
IRCT20190706044111N18Alborzdarou Pharm. Co.24
尚未招募
不适用
Bioequivalence study of Domperidone 10mg tablet of Amin Pharm Co., IRA
IRCT20190706044111N24Amin Pharm. Co.48
尚未招募
不适用
Bioequivalence study of Gabapentin 300mg capsule of Alborzdarou Pharm Co.,euralgia and neuropathic disorders.
IRCT20190706044111N6Alborzdarou Pharm. Co.24
已完成
不适用
Bioequivalence study of Rosuvastatin 20 mg tablet of Aburaihan Pharm Co., IRAHyperlipidemia.
IRCT20190706044111N9Aburaihan Pharm Co.24
已完成
不适用
Bioequivalence study of Aristatin 10mg tablet of Arya Pharm Co., IRAHyperlipidemia.
IRCT20190706044111N8Arya Pharm Company24