CTRI/2020/09/027593已完成1 期
An open label, balanced, randomized, single oral dose, two treatment, two sequence, two period, crossover bioequivalence study of test product, Darunavir and Ritonavir Tablet 800mg 100mg of Emcure Pharmaceuticals Ltd, India and reference product, DANAVIR R Darunavir & Ritonavir Tablet 800mg 100mg of Hetero Healthcare Limited, India in healthy, adult, human subjects under fed conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
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
- •1.0 Healthy, human subjects (Male and/or non-pregnant, non-lactating female) aged between 18 and 45 years (inclusive of both).
- •2.0 Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to initiation of the study. Female subject must have a negative urine pregnancy test prior to check-in of each period. They must be using an acceptable form of contraception.
- •3.0 For female 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 07 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.
- •4.0 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.
- •5.0 Male agreeing to use appropriate contraceptive measures like Double Barrier method (Condom), and should not donate sperm etc. during study and 07 days after completion of study.
- •6.0 Subjects with a BMI between 18.50-25.00 kg/m2 (inclusive of both) and body mass not less than 50.00 kg.
- •7.0 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).
- •8.0 Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording
- •9.0 Subjects having a normal or clinically not significant chest X-Ray (P/A view).
- •10.0 A negative urine screen result for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).
- •11.0 A negative alcohol breath test result.
- •12.0 A negative urine screen result for cotinine during screening.
- •13.0 Subject able to communicate effectively and provide written informed consent.
- •14.0 Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by ethics committee.
- •15.0 Subjects that can provide adequate evidence of their identity.
- •16.0 Availability of volunteer for the entire study duration.
- •17.0 Ability to fast for at least 10.00 hours and consume high-fat high-calorie non veg breakfast and standard meals.
排除标准
- •The subjects will be excluded from the study if they meet any of the following criteria:
- •1.0 Known hypersensitivity to Darunavir and Ritonavir or any component of this medication.
- •2.0 Incapable of understanding the informed consent information.
- •3.0 History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •4.0 Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within one month of starting the study.
- •5.0 History or presence of alcoholism or drug abuse.
- •6.0 History or presence of asthma, urticaria or other allergic reactions.
- •7.0 History or presence of gastric and/or duodenal ulceration.
- •8.0 History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion.
- •9.0 History or presence of cancer.
- •10.0 Difficulty with donating blood.
- •11.0 Difficulty in swallowing solids like tablets or capsules.
- •12.0 Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week prior to study initiation and throughout the study.
- •13.0 Consumption of alcohol and/or smoking or consumption of tobacco products within 48.00 hours prior to dosing.
- •14.0 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.
- •15.0 Subject consumed caffeine and /or xanthine-containing foods or beverages (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and grapefruit or grapefruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and throughout the study.
- •16.0 Major illness during the 90 days before screening.
- •17.0 Participation in a drug research study within 90 days of screening.
- •18.0 Donation of blood within 90 days of screening.
- •19.0 Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL.
- •20.0 History or presence of easy bruising or bleeding.
- •21.0 Abnormal diet pattern for whatever reason (e.g. low sodium, fasting, and high protein diets) during the four weeks preceding the study.
- •22.0 Pregnant woman and nursing mothers.
- •23.0 Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
- •24.0 Woman of child bearing age who do not agree to follow a reliable method of contraception during study period.
- •25.0 Male volunteer unwilling to employ appropriate contraceptive measures to ensure that his partner will not get pregnant during the study till 07 days after the completion of study.
- •26.0 Male volunteer willing to donate sperms during the study till 07 days after the completion of study.
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