EUCTR2020-003396-18-NL进行中（未招募）1 期
A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Adult Participants to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg when Administered as a Fixed Dose Combination (Darunavir/Cobicistat/ Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Must be a man or woman between 18 and 55 years of age, extremes included, at screening.
- •2. Must have a body mass index (BMI; weight [kg]/height2 [m]2) between 18.5 and 30.0 kg/m2 (extremes included), and a body weight of not less than 50 kg at screening.
- •3. Must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study, before any study-related procedures take place.
- •4. Must be healthy on the basis of physical examination, medical history, vital signs, and ECG performed at screening (results must be available on Day -1). If there are abnormalities (other than those listed in inclusion criterion 10 [for blood pressure]), the participant may be included only if the investigator judges the abnormalities or
- •deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator.
- •5. Participant must be healthy on the basis of clinical laboratory test performed at screening (results must be available on Day -1). If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges (other than those listed in exclusion criterion 2), the participant may be included only if the
- •investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator.
- •6. A woman (of childbearing potential) must have a negative highly sensitive serum betahuman chorionic gonadotropin (?-hCG) pregnancy test, 4 days or less before dosing of the first treatment period.
- •7. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies.
- •Before randomization, a female participant must be either:
- •a. Not of childbearing potential defined as:
- •-premenarchal
- •A premenarchal state is one in which menarche has not yet occurred
- •-postmenopausal
- •A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level (>33.4 IU/L or mIU/mL in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. If there is a question about menopausal status in women on hormone replacement therapy (HRT), the woman will be required to use one of the non-estrogen-containing hormonal highly effective contraceptive methods if she wishes to continue HRT during the study.
- •-permanently sterile
- •Permanent sterilization methods include hysterectomy, bilateral
- •salpingectomy, bilateral tubal occlusion/ligation procedures, and
- •bilateral oophorectomy.
- •b. Of childbearing potential and
- •-be not heterosexually active, or have a vasectomized partner for the
- •duration of the study and for at least 90 days after receiving the last dose of study drug OR
- •-practicing a highly effective method of birth control (as specified below) before entry and agree to continue to use a highly effective method of contraception throughout the study, and for at least 90 days after receiving the last dose of study drug. Women with tubal ligation are required to use one additional contraceptive method. Note: Estrogenbased hormo
排除标准
- •1. Has history or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease (including bronchospastic respiratory disease), diabetes mellitus, hepatic or renal insufficiency (eg, estimated creatinine clearance below <90 mL/min at screening), gastrointestinal disease (such as significant diarrhea, gastric stasis, or constipation that in the investigator’s opinion could influence drug absorption or bioavailability), thyroid disease, neurologic or psychiatric disease,
- •infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
- •2. Had one or more of the following laboratory abnormalities at screening as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events and in accordance with the normal ranges of the clinical laboratory:
- •-Serum creatinine Grade 1 or greater (=1.1 x upper limit of laboratory normal range [ULN]) or creatinine clearance (using the CKD-EPI
- •formula) <90 mL/min.
- •-Lipase Grade 1 or greater (=1.1 x ULN), and/or total amylase Grade 2 or greater (=1.5 x ULN).
- •-Hemoglobin (Hb) Grade 1 or greater (Female: =7.2 mmol/L and Male: =8.3 mmol/L).
- •-Platelet count Grade 1 or greater (<124.999 x 109/L).
- •-Absolute neutrophil count Grade 1 or greater (=1.0 x 109/L).
- •-Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) Grade 1 or greater (=1.25 x ULN).
- •-Total bilirubin Grade 2 or greater (=1.6 x ULN).
- •-Note: Participants with documented Gilbert’s syndrome could have total bilirubin up to 5 x ULN.
- •-For proteinuria (spot urine) =2+.
- •-Microscopic hematuria (=5 red blood cells [RBC]/hpf); if a female
- •participant is menstruating at the time of screening a urine retest is to be performed after the menstrual period.
- •-Any other laboratory abnormality of grade 2 or greater. For low-density lipoprotein (LDL) cholesterol values corresponding to DAIDS grade 2 or greater, participants will not to be excluded as long as the value is not higher than ULN of the local lab.
- •Note: Retesting of abnormal lab values that could lead to exclusion will be allowed once. Retesting will take place during an unscheduled visit in the screening phase.
- •3. Clinically significant abnormalities during physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at admission to the study center as deemed appropriate by the investigator.
- •4. With any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria.
- •5. Has taken any disallowed therapies as noted in Section 5.5 before the planned first intake of study drug.
- •6. Has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 1 year before screening or positive test result(s) for alcohol and/or drugs of abuse (such as hallucinogens, barbiturates, opiates, opioids, cocaine, cannabinoids, amphetamines, methadone,
- •benzodiazepines, methamphetamine, tetrahydrocannabinol, phencyclidine, and tricyclic antidepressants) either at screening or on Day -1 of each treatment period.
- •7. With a history of clinically significant drug allergy such as, but not limited to,
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