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临床试验/CTRI/2023/12/060423
CTRI/2023/12/060423尚未招募1 期

An open label, balanced, randomized, two-treatment, two-period, cross-over, oral comparative bioavailability study comparing test product, Bilastine 3.3mg + Dextromethorphan Hydrobromide 10mg + Phenylephrine Hydrochloride 5mg/5mL Syrup of Synokem Pharmaceuticals Ltd., India with reference product, BilazestTM Kids (Bilastine Oral Solution 2.5mg/mL) of Akums Drugs & Pharmaceuticals Ltd., India in healthy, adult, human subjects under fed condition - NI

Synokem Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
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试验速览

阶段
1 期
状态
尚未招募
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

入选标准

  • •1. Healthy, non-smoking, non-alcoholic human subjects (Male and/or non-pregnant,
  • •non-lactating female) aged between 18 and 45 years (inclusive of both).
  • •2. Female of childbearing potential must have a negative urine pregnancy test
  • •performed within 21 days prior to initiation of the study. Female subject must have a
  • •negative serum beta human chorionic gonadotropin (ß-HCG) pregnancy test prior to
  • •check-in of each period. They must be using an acceptable form of contraception.
  • •3. For female of childbearing potential, acceptable forms of contraception include the
  • •i. Non-hormonal intrauterine device in place for at least 3 months prior to the
  • •start of the study and remaining in place during the study period and for 07
  • •days following last dose of the study medication, or
  • •ii. Barrier methods containing or used in conjunction with a spermicidal agent,
  • •iii. Surgical sterilization or
  • •iv. Practicing sexual abstinence throughout the course of the study
  • •4. Female will not be considered of childbearing potential if one of the following is
  • •reported and documented on the medical history:
  • •i. Postmenopausal with spontaneous amenorrhea for at least one year, or
  • •ii. Bilateral oophorectomy with or without a hysterectomy and an absence of
  • •bleeding for at least 6 months, or
  • •iii. Total hysterectomy and an absence of bleeding for at least 3 months.
  • •5. Subjects with a BMI between 18.50-30.00 kg/m2
  • •(inclusive of both) and weight not
  • •less than 50.00 kg.
  • •6. Subjects in normal health as determined by personal medical history, clinical
  • •examination including vital signs and clinically acceptable results of laboratory
  • •examinations (including serological tests).
  • •7. Subjects having a normal or clinically not significant 12-lead electrocardiogram
  • •(ECG) recording.
  • •8. Subjects having a normal or clinically not significant chest X-Ray (P/A view).
  • •9. A negative urine screen result for drugs of abuse (including amphetamines,
  • •barbiturates, benzodiazepines, marijuana, cocaine and morphine).
  • •10. A negative alcohol urine test or alcohol breath test result.
  • •11. Subject able to communicate effectively and provide their informed consent.
  • •12. Subjects willing to adhere to the protocol requirements as evidenced by informed
  • •consent approved by ethics committee.
  • •13. Subjects that can provide adequate evidence of their identity.
  • •14. Availability of volunteer for the entire study duration.
  • •15. Ability to fast for at least 10.00 hours and consume high-fat high-calorie non vegetarian breakfast and standard meals.
  • •16. Subject agreeing to use appropriate contraceptive measures including practice
  • •abstention or contraception or Double Barrier method during study and 07 days after
  • •completion of study

排除标准

  • •1. Known hypersensitivity to Bilastine and/or Dextromethorphan hydrobromide and/or
  • •Phenylephrine hydrochloride or to related drugs or any component of this
  • •medication.
  • •2. Incapable of understanding the informed consent information.
  • •3. History or presence of significant cardiovascular, pulmonary, hepatic, renal,
  • •gastrointestinal, endocrine, immunological, dermatological, neurological or
  • •psychiatric disease or disorder.
  • •4. Any treatment which could bring about induction or inhibition of hepatic microsomal
  • •enzyme system within one month of starting the study.
  • •5. History or presence of seizure or psychiatric disorders.
  • •6. History or presence of smoking or consumption of tobacco products.
  • •7. History or presence of alcoholism or drug abuse.
  • •8. History or presence of asthma, urticaria or other allergic reactions.
  • •9. History or presence of gastric and/or duodenal ulceration.
  • •10. History or presence of thyroid disease, adrenal dysfunction, organic intracranial
  • •11. History or presence of cancer.
  • •12. Difficulty with donating blood
  • •13. Use of any prescribed medication (including herbal remedies and vitamins) during
  • •the two weeks before the start of the study or OTC medicinal products during one
  • •week prior to study initiation and throughout the study.
  • •14. Use of ketoconazole, erythromycin, diltiazem, lorazepam, monoamine oxidase
  • •inhibitors (MAOIs), CYP2D6 inhibitors, sympathomimetic amines, beta-blockers,
  • •other antihypertensives, tricyclic antidepressants, ergot alkaloids, digoxin and cardiac
  • •glycosides, warfarin and other coumarins) during the two weeks before the start of
  • •the study and throughout the study.
  • •15. Subject consumed caffeine and/or xanthine-containing foods or beverages (i.e.
  • •coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.), grapefruit and/ or
  • •its juice and poppy containing foods for at least 48.00 hours prior to initiation of the
  • •study and throughout the study.
  • •16. Major illness during the 90 days prior to check-in.
  • •17. Participation in a drug research study within 90 days prior to check-in.
  • •18. Donation of blood within 90 days prior to check-in.
  • •19. Positive screening test result for any one or more of the following: HIV, Hepatitis B,
  • •Hepatitis C and VDRL.
  • •20. History or presence of easy bruising or bleeding.
  • •21. Abnormal diet pattern for whatever reason (e.g. low sodium, fasting, and high
  • •protein diets) during the four weeks preceding the study.
  • •22. Pregnant woman and nursing mothers.
  • •23. Female volunteer who has used implanted or injected hormonal contraceptives
  • •anytime during the 6 months prior to study or used oral hormonal contraceptives
  • •within 14 days before dosing.
  • •24. Woman of child bearing age who do not agree to follow a reliable method of
  • •contraception during study period.

研究者

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