CTRI/2017/10/010040已完成1 期
A Phase I, Single-centre, Randomized, Double-Blind, Two Treatment, Two-Period, Two-sequence, Two-way Crossover Study to Demonstrate Equivalence of Pharmacokinetic and Pharmacodynamic Characteristics and to Compare Safety and Tolerability of Granulocyte Colony Stimulating Factor (BioGenomics Limited) and Neupogen® Administered via Subcutaneous Route as Multiple Consecutive Doses in Healthy Adult Human Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
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
入选标准
- •Inclusion Criteria
- •1. Willingness to provide informed consent to participate in the study.
- •2. Body Mass Index (BMI) between 18.0 kg/m2 to 27.0 kg/m2 (both inclusive) with minimum weight of 50 kg.
- •3. Nonalcoholic, nonsmoker, healthy, adult, human male volunteers of any race within the age range of 18 to 45 years (both inclusive)living in and around Ahmedabad city or Western part of India.
- •4. No history of any major illness in the past or absence of clinically significant abnormal findings in physical examination, laboratory evaluations, 12-lead Electrocardiogram (ECG) and X-ray chest Postero-anterior (PA) view during screening.
- •5. Hemoglobin: >=12.0 gm%.
- •6. Subjects without any evidence of impaired glucose tolerance in 2 hour Oral Glucose Tolerance Test (OGTT) at screening.
- •7. Absence of disease markers of HIV I & II, a negative P24 antigen test, negative Hepatitis B Surface Antigen (HBsAg) and Hepatitis C
- •Virus Antibody (HCVAb).
- •8. Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire procedure.
- •9. Negative breath alcohol test at every check-in.
- •10. Negative urine drug abuse test (barbiturates, benzodiazepines,
- •opioids, cocaine, cannabinoids and amphetamine, etc.) at every check-in. (This test will be done at the clinical facility).
- •Exclusion Criteria
- •1. History / evidence of allergy or hypersensitivity to any drug
- •2. Any major illness in the last three months or any significant ongoing chronic medical illness
- •3. Recent history or presence of active kidney or liver dysfunction.
- •4. Active deep vein thrombosis, pulmonary embolism, arterial thromboembolic disorders or a history of these conditions.
- •5. History of or current gastrointestinal diseases influencing drug absorption
- •6. History of drug abuse (including barbiturates, benzodiazepines,
- •opioids, cocaine, cannabinoids and amphetamine etc.) within last 3 months.
- •7. History of hyperglycaemia (symptoms include nausea, vomiting,drowsiness, flushed dry skin, dry mouth, increased frequency of urination, thirst and loss of appetite as well as acetone breath).
- •8. History of diabetic ketoacidosis.
- •9. History of hypoglycaemia (symptoms include low pulse rate, watering of extremities, dizziness, weakness and sometimes
- •10. A history of neuropsychiatric diseases.
- •11. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the start of
- •12. History or presence of asthma, urticaria or other allergic reactions.
- •13. History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
- •14. History or presence of cancer.
- •15. Consumption of xanthine-containing food and beverages (chocolates, tea, coffee or cola drinks) and tobacco products (Gutka or Pan masala) 48.00 hours prior to check-in.
- •16. Consumption of grapefruit, grapefruit juice/ products and poppy-containing food and beverages within at least 48.00 hours prior to every check-in.
- •17. History of difficulty with donating blood or difficulty in accessibility ofveins in left or right arm.
- •18. Donation of blood (1 unit) within 90 days prior to the first dose of the study drug or have blood loss, excluding volume drawn at sc
排除标准
- •1. Allergy or significant history of hypersensitivity or idiosyncratic reaction to E.coli-derived proteinsâ?? G-CSF or any other excipients in the particular product.
- •2. Cardiovascular, pulmonary, hepatic, renal, hematological, endocrinal, gastrointestinal, immunologic, dermatologic, neurological or psychiatric disease.
- •3. Having systolic blood pressure <100 and >130 mmHg, diastolic blood pressure <60 and >88 mmHg and pulse rate <60 and >100
- •4. Subjects who have been on an unusual diet (for whatever reason, less than 200 kilocalories (kcal) and more than 3000 kcal during the four weeks preceding the study
- •5. Use of drugs which may potentiate the release of neutrophilsâ?? such as lithiumâ?? in the previous 30 days before the study.
- •6. Female subjects who are currently breast feeding or pregnant or post menopausal (by history or as evidenced by hormonal results)
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