NL-OMON49638招募中不适用
A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects 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 Coadministration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions - Bioequivalence Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •1. Must be a man or woman between 18 and 55 years of age, extremes included, at
- •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
- •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 the subject 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 subject's source
- •documents and initialed by the investigator.
- •5. Subject 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 subject 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 subject's source documents and initialed by the investigator.
- •6. A woman (of childbearing potential) must have a negative highly sensitive
- •serum betahuman chorionic gonadotropin pregnancy test, 4 days or less before
- •the first treatment period.
排除标准
- •Any potential subject who meets any of the following criteria will be excluded
- •from participating in the study:
- •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 subject 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
- •- 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).
- •- For proteinuria (spot urine) >=2+.
- •- Microscopic hematuria (>=5 red blood cells [RBC]/hpf); if a female subject 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,
- •subjects will not to be excluded as long as the value is not higher than ULN of
- •the local lab.
- •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
- •5. No medication, including over-the-counter products, systemic herbal
- •medications or dietary supplements including products containing Hypericum
- •perforatum (St. John*s wort) can be used at least 14 days (or longer, based on
- •5 times the elimination half-life) before the first intake of study drug (on
- •Day 1 of the first treatment period) until collection of the last PK sample,
- •except for paracetamol (acetaminophen) or ibuprofen, hormone replacement
- •therapy in postmenopausal women, and hormone-based contraception.
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