CTRI/2020/03/023731尚未招募1 期
A randomized, open-label, balanced, four-treatment, four-period, four-sequence, single-dose, crossover, comparative pharmacokinetics and bioavailability study of fixed dose combination test product (T) of Naltrexone Hydrochloride and Zonisamide Sustained Release Capsules 32mg/91mg of Dr. Reddyâ??s Laboratories Ltd., India compared with R1 [Naltrexone Hydrochloride Tablets USP 50 mg of SpecGx LLC (Mallincknodt, Inc., USA)], R2 [Zonegran (Zonisamide) Capsule 100 mg of Concordia Pharmaceuticals Inc, Barbados, USA] and R3 [Co-administration of Naltrexone HCl: Naltrexone Hydrochloride Tablets USP 50 mg of SpecGx LLC (Mallincknodt Inc., USA) and Zonegran (Zonisamide) Capsule 100 mg of Concordia Pharmaceuticals Inc, Barbados] in normal healthy adult human subjects under fasting condition.
Dr Reddys Laboratories Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Normal healthy, adult, human subjects, age between 18 to 45 years (inclusive of both).
- •2. Body mass index of ï?³ 18.5 kg/m2 and ï?£ 24.9 kg/m2 and weight ï?³ 50.00 kg.
- •3. Healthy according to the laboratory results and physical examination, performed within 21 days prior to the commencement of the dosing of the study period.
- •4. Subject whose clinical laboratory values are within normal limits or clinically insignificant as determined by physician or principal investigator to be of no clinical significance.
- •5. Have clinically acceptable ECG, Chest X-ray and vital signs
- •6. Non-Alcoholics.
- •7. Non-smoker
- •8.Subject able to communicate effectively and willing to provide written informed consent
- •9. Subject willing to adhere to protocol requirements as evidenced by written informed consent approved by an Independent Ethics Committee (IEC).
- •10. If study subject is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence:
- •is postmenopausal for at least 1 year
- •is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject).
- •11. Male subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as (a double barrier method) Condom with spermicide, Condom with diaphragm, or abstinence.
- •12. Male subjects willing to agree not to donate sperm during the study.
排除标准
- •1. Any history of allergy or hypersensitivity to Naltrexone Hydrochloride and Zonisamide or any of its excipients or other related drugs.
- •2. Positive test result for hepatitis B surface antigen (HBs Ag), hepatitis C virus antibody (HCV Ab) or HIV-1 antibody or HIV Type 2 (HIV-2) antibody (HIV Ab) or VDRL / syphilis.
- •3.The study drug is contraindicated for medical reasons.
- •4. Any history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, dermatological, neurological, psychiatric and Eye diseases or disorders.
- •5. History or presence of seizures, movement disorders, significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
- •6. History or presence of cancer
- •7. History or presence of significant easy bruising or bleeding.
- •8. History or presence of significant recent trauma.
- •9. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- •10. History or presence of significant gastric and/or duodenal ulceration.
- •11. Consumption of xanthine-containing products, tobacco containing products within 48 hours and grapefruit or grapefruit juice within 72 hours prior to dosing of period 1.
- •12. Use of any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month prior to dosing.
- •13. Amenorrhea or irregular menstrual periods (defined unable to predict within 7 days) during past 6 months for females.
- •14. History or presence of drug abuse in the past one year.
- •15. Difficulty in swallowing tablets or capsules.
- •16. Any history of difficulty in donating blood.
- •17. Had clinically significant abnormal values of laboratory parameters
- •18. Subject having Modified Patient Health Questionnaire (PHQ) 12 questionnaires >4
- •19. Blood pressure is < 100/60 and > 129/79 millimeters of mercury (Systolic blood pressure/ Diastolic blood pressure).
- •20. Pulse rate less than 60 beats / minute and more than 100 beats / minute.
- •21. Usage of any prescribed medication during last 14 days and for OTC medicinal products, herbal products during the last 07 days preceding first dosing of the study.
- •22. Female subject who is currently breast feeding or a female study subject who is pregnant or who is likely to become pregnant during the study.
- •23. Female subject demonstrating positive for pregnancy test (performed at the time of each period check-in).
- •24. Any clinically significant illness during 3 months before screening.
- •25. Participation in a drug research study/donation of blood within past 90 days.
- •26. Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug.
研究者
相似试验
已完成
不适用
Comparative Bioavailability study of Diclofenac Topical solution (4%) vs Diclofenac Gel (1%)CTRI/2022/11/047283Troikaa Pharmaceuticals Ltd
已完成
不适用
To study the bioavailability and bioequivalence of four Ashwagandha extracts in healthy adultsCTRI/2020/10/028397Arjuna Natural Private Limited16
已完成
不适用
A randomized, open-label, multiple dose, four-way crossover pharmacodynamic equivalence study comparingOrlistat 60mg and 120mg hard gelatin capsules in healthyvolunteers.CTRI/2011/12/002292aboratorios Liconsa SA60
已完成
不适用
A study of CPL-2009-0031 140mg Tablets of Cadila Pharmaceuticals with JANUVIA 100mg Tablets of MSD Pharmaceuticals in healthy subjects.CTRI/2020/01/022665Cadila Pharmaceuticals Limited16
已完成
不适用
Pharmacodynamic and pharmacokinetic study of PEG Neutrogen 6 mg subcutaneous injectioCTRI/2015/12/006426Virchow Biotech Private Limited24