CTRI/2018/02/011802招募中未知
A single arm, single-dose, safety and pharmacokinetic study of ReliBeta® (Interferon beta-1a 2x30 micrograms pre-filled syringe) from Reliance Life Sciences Pvt. Ltd., India in normal, healthy, adult, human subjects under fasting conditions.
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 20
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.Healthy subject of either sex aged between 18 to 45 years (both inclusive)
- •2.Subjects with Body Mass Index (BMI) 18.5 to 24.9 kg/m2 (both inclusive)
- •3.Subjects who are able to understand and willing to comply with the protocol requirements
- •4.Subjects who are able to understand and willing to voluntarily provide written informed consent.
- •5.Subjects who are able to understand and willing to adhere to protocol and the following study requirements:
- •Should not consume xanthine containing products, such as coffee, tea, chocolate or soft drinks at least 24 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) and until the last sample collection.
- •Should not consume alcohol at least 48 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) and until the last sample collection.
- •Should not consume grapefruit or its products at least 7 days prior to dosing (i.e. in house monitoring and the remaining based on history) and until the last sample collection.
- •6.Subjects who are non-smokers (based on history).
- •7.Subjects having no clinically significant medical history and no clinically significant
排除标准
- •Subjects incapable of understanding and signing the informed consent document
- •2. Pregnant and lactating women (currently breast-feeding). Presence of pregnancy will be confirmed by Serum (β) Beta-hCG (Human Chorionic Gonadotropin) test before check-in.
- •3. Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria at least 14 days prior to the first dose of study medication until the post-study follow-up. Use of hormonal contraceptives either oral or implants will not be acceptable.
- •4. Subjects with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study
- •5. Subjects with abnormalities in resting heart rate (100 beats/min or 50 beats/min) and blood pressure either hypotensive episode (systolic blood pressure 90 mmHg or diastolic blood pressure 60 mmHg) or hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg) on the screening day
- •6.Subjects with active history of psychiatric disorders, which are likely to limit the validity of consent to participate in the study, or limit the ability to comply with the protocol requirements
- •7.Subjects suffering from gastro-esophageal reflux/upper G.I. motility disorders
- •8.Subjects with any evidence of organ dysfunction or any clinically significant deviation from the normal in their physical or clinical evaluation
- •9. Use of any concomitant medication (including prescription, OTC and herbal remedies) during the two weeks prior to initiation of study.
- •10.Subject with a known history of drug hypersensitivity to interferon beta-1a or any excipient of its formulation or related drugs
- •11. Subjects with a history of drug abuse or alcohol abuse and who are found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates) or are found with current alcohol abuse based on Alcohol breath test.
- •12. Subjects diagnosed to be HIV 1 or 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
- •13. Subjects with clinically significant abnormal values of hemoglobin (Hb), total white blood cells count (WBC), differential WBC count, platelet count or hematocrit.
- •14. Subjects with clinically significant abnormal laboratory values for serum creatinine, blood urea nitrogen, (BUN), serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase (ALP), serum bilirubin, serum glucose (fasting), or serum cholesterol.
- •15. Subjects with clinically significant abnormal urine analysis, defined as the presence of RBC (5/HPF), pus cells ( 5/HPF), epithelial cells ( 5/HPF), glucose (positive) and protein (positive) in urine (unless the Investigator considers the deviation to be irrelevant for the purpose of the study).
- •16. Subjects with pre-existing conditions such as ischemic heart disease, history of myocardial infarction, congestive heart failure, history of cardiac arrest, cerebrovascular disease, history of symptomatic bradycardia, history of recurrent syncope, severe untreated sleep apnea, AV block, and sino-atrial heart block will be excluded from the study
- •17. Subjects with a prolonged QTc interval 450 msec males, 470 msec females at the time of Screening or at additional risk for QT prolongation (e.g., hypokalemia,
研究者
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