CTRI/2022/10/046360尚未招募1 期
A phase I Non-randomized single sequence One-way interaction study of HRF-10071 tablet 120mg on pharmacokinetics of Metoprolol 100mg and Pravastatin 40mg Under fasting conditions
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
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 human subjects of either sex aged between 18 and 45 years (inclusive of both).
- •2.Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (Ã?²-HCG) pregnancy test performed within 21 days prior to initiation of the study. Women must have a negative (Ã?²-HCG) pregnancy test prior to check-in of each treatment. They must be using an acceptable form of contraception.
- •3.For women of childbearing potential, acceptable forms of contraception include the following:
- •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 10 days following last dose of the study medication, or
- •ii.Barrier methods containing or used in conjunction with a spermicidal agent, or
- •iii.Surgical sterilization or
- •iv.Practicing sexual abstinence throughout the course of the study.
- •4.Women 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.Men agreeing to use appropriate contraceptive measures like Double Barrier method (condom + diaphragm, condom or diaphragm + spermicidal gel or foam), and should not donate sperm etc. during study and 10 days after completion of study.
- •6.Subjects with a BMI between 18.50-30.00 kg/m2 (inclusive of both) and body weight not less than 50.00 kg.
- •7.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).
- •8.Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording.
- •9.Subjects having a normal or clinically not significant chest X-Ray (P/A view).
- •10.A negative urine screen result for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •11.A negative alcohol urine test or alcohol breath test result.
- •12.Subject able to communicate effectively and provide written informed consent.
- •13.Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by ethics committee.
- •14.Ability to fast for at least 14.00 hours and consume standard meals.
排除标准
- •1.Known hypersensitivity to Metoprolol and/or Pravastatin and/or HRF-10071 or any component of this medication.
- •2.Incapable of understanding the informed consent information.
- •3.History or presence of significant haemopoetic, 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 alcoholism or drug abuse.
- •6.History or presence of asthma, urticaria or other allergic reactions.
- •7.History or presence of gastric and/or duodenal ulceration.
- •8.History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion.
- •9.History or presence of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- •10.History or presence of cancer.
- •Difficulty with donating blood.
- •11.Difficulty in swallowing solids like tablets or capsules.
- •12.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 the week prior to initiation of study and until the end of the study.
- •13.Use of cytochrome P450 inhibitors, calcium antagonists, Class I-antiarrhythmics and beta-receptor blockers, Non-steroidal anti-inflammatory drugs, antihypertensive medications, and monoamine oxidase inhibitors (MAOIs), parasympathomimetics, sympathomimetics, general anaesthetics, antidiabetic agents, Vitamin K antagonists, Warfarin and other oral anticoagulants during two weeks prior to initiation of study and until the end of the study.
- •14.Subject consumed tobacco/ tobacco containing products, pan or pan masala, gutkha, masala (containing beetle nut and tobacco) for at least 48.00 hours prior to initiation 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.) and grapefruit and/ or its juice and poppy containing foods for at least 48.00 hours prior to initiation of study and until the end of the study.
- •16.Major illness within 90 days before screening and till treatment 01 check-in.
- •17.Participation in a drug research study within 90 days prior to screening.
- •18.Donation of blood within 90 days prior to screening.
- •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 two weeks prior to initiation of study.
- •22.Pregnant woman and nursing mothers.
- •23.Women who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 10 days before dosing.
- •24.Women of childbearing age who do not agree to follow a reliable method of contraception during study period.
- •25.People who are employed by the CRO (that is employees, temporary contract workers, designees responsible for study conduct).
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