CTRI/2018/02/011700尚未招募未知
An Assessor-blind, Balanced, Randomized, Two-treatment, Two-period, Single-dose, Two-way, Crossover, Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects Under Fed Condition.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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. Normal, healthy adult human volunteers between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
- •2. Having body weight greater than or equal to 50 kg and body mass index (BMI) between 18.5 to 29.9 (both inclusive), calculated as weight in kg/height in meter square.
- •3. Not having any significant disease in medical history or clinically significant abnormal findings during screening, abdominal ultrasonography, medical history, clinical examination, laboratory evaluations, 12-lead ECG and X-ray chest (P/A view; within the last 6 months) recordings.
- •4. Volunteer who is a Non-smoker
- •5. Able to understand and comply with the study procedures, in the opinion of the investigator.
- •6. Able to give voluntary written informed consent for participation in the trial.
- •7. In case of female subjects:
- •a. Surgically sterilized at least 6 months prior to study participation;
- •If a woman of child bearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
- •b. Serum pregnancy test (for female subjects) must be negative
排除标准
- •1. Known hypersensitivity to the study drug or its constituents and/or hypersensitivity to E. coli-derived proteins, and/or previous exposure to the study drug
- •2. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •3. Known case of hereditary fructose intolerance
- •4. Subjects with latex allergies will be excluded as the needle cover on the single-use prefilled syringe contains dry natural rubber (latex).
- •5. Any clinically significant laboratory finding including ANC, platelet, RBC count or hemoglobin level at the time of screening.
- •6. Prior exposure to any peptide colony stimulating or growth factor, including erythropoietin, filgrastim or Pegfilgrastim; Prior exposure to vaccines, immunoglobulin preparations, or immunomodulatorâ??s within the past 6 months prior to receiving the first dose; evidence of E coli diarrhea or diseases within 3 months.
- •7. Any history or presence of asthma (including aspirin-induced asthma) or nasal polyp or NSAIDs-induced urticaria.
- •8. Subjects with a history of pulmonary infiltrate or pneumonia in the last 6 months.
- •9. History of any hematologic disease including sickle cell disorders.
- •10. Smokers, or who have smoked within last six months prior to start of the study.
- •11. Ingestion or use of any prescribed medication at any time within 1 month prior to receiving first dose in period I.
- •12. Receipt of over-the-counter medicines which have not yet cleared from the body (5 half-lives must have passed for the medicine to be considered to have cleared from the body).
- •13. A recent history of harmful use of alcohol, i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc.) or consumption of alcohol or alcoholic products within 72 hours prior to receiving study medicine in period-I.
- •14. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •15. Donation of blood (1 unit or 350 mL) or equivalent amount of blood substitute. Receipt of an investigational medicinal product or participation in a drug research study within a period of 180 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
- •16. Positive result for human immunodeficiency virus (HIV I &/or II) and/or hepatitis B and C tests.
- •17. History or presence of cancer because of which anticipated life span is less than 5 years as per the investigatorâ??s assessment.
- •18. History or presence of psychiatric disorders.
- •19. Presence of tattoo or scars or any type of skin lesions due to infection, burning, wound or inflammation at the proposed site of injection.
- •20. An unusual diet, for whatever reason (e.g. low-sodium), for 4 weeks prior to receiving the study medicine in period-I. In any such case, subject selection will be at the discretion of the Principal Investigator.
- •21. Consumption of grape fruit or grape fruit products within 72 hours prior to receiving study drug in period-I. <br/
研究者
相似试验
尚未招募
1 期
A pharmacokinetic and pharmacodynamic study of pegfilgrastim (test drug) with Neulasta of Amgen (reference drug, EU Licensed Product) in normal adult human subjects under fasting conditions.CTRI/2016/07/007096Intas Pharmaceuticals Ltd344
已完成
不适用
2 PERIOD FASTING STUDY IN HEALTHY, NORMAL, ADULT, HUMAN MALE, RANDOMLY DOSED IN EACH PERIOD WITH OLNP-18 OR STANDARD CURCUMINOIDSCTRI/2019/07/020467Olene Life Sciences Private Limited18
尚未招募
Unknown
A Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Electroacupuncture and Its Cotreatment with Electronic Moxibustion for Dry eye syndromeKCT0009622aju Dongshin University Korean Medicine Hospital45
已完成
1 期
A comparative pharmacokinetic and pharmacodynamic study of insulin aspart protamine suspension administered as subcutaneous injection in healthy subjects.CTRI/2023/07/055238Mankind Pharma Limited, India36
招募中
2 期
This is a study on the effectiveness of an Oral supplement on hair growth in women when compared with a marketed product.CTRI/2018/05/013975Atlantic Coast Brands