NL-OMON49227已完成不适用
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 Con - D/C/F/TAF and combination bioequivalence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- •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 (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.
- •Further criteria apply.
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
- •infection, or any other illness that the investigator considers should exclude
- •the participant or that could interfere with the interpretation of the study
- •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).
- •- 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.
- •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. Has taken any disallowed therapies as noted in Section 5.5 of the protocol
- •before the planned first intake of study drug.
- •Further criteria apply.
研究者
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