EUCTR2016-004323-23-Outside-EU/EEA进行中（未招募）1 期
An open-label, randomized, single dose, two period, crossover study to determine the bioequivalence between valsartan 160 mg pediatric final market image (FMI) formulation (solution) and clinical service form (CSF) of valsartan 160 mg extemporaneous suspension in healthy adult volunteers. - Bioequivalence study for valsartan 160 mg solution and valsartan 160 mg
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ovartis
- 入组人数
- 86
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
- •Healthy male and female subjects age 18-55 years Vital signs :Oral Body temperature 35.0 - 37.5°C, systolic blood pressure 90 - 140 mm Hg, diastolic blood pressure 60 - 90 mm Hg, pulse rate 45 - 90 bpm , BMI 18-30 kg/m2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 86
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Use of any prescription medications, herbal supplements, or Over the counter medications,
- •2. Participation in any clinical investigation within four (4) weeks prior to initial dosing
- •3. Donation or loss of 400mLor more of blood within 8 weeks prior to initial dosing
- •4. Significant illness within two (2) weeks prior to initial dosing, a past medical history of clinically significant ECG abnormalities, recent and/or recurrent history of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc), Recent or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated), history of multiple and recurring allergies or allergy to valsartan or its class being used in this study
- •5. Any planned surgery or procedure within 3 months of screening
- •6.Pregnant or lactating females
- •7.Presence of clinically significant abnormal lab values during screening
- •8.Any surgical or medical condition that would significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which could jeopardize the subject in case of participation in the study.
- •9.History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result , a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- •10.History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening and at each baseline
- •11. Presence of contraindications to the study treatments
研究者
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