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
- 64
- 试验地点
- 1
- 主要终点
- To demonstrate equivalence of PK and PD characteristics of G-CSF of Biogenomics and Neupogen® after multiple SC injections in healthy adult human volunteers.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Inclusion Criteria
- •Willingness to provide informed consent to participate in the study.
- •Body Mass Index (BMI) between 18.0 kg/m2 to 27.0 kg/m2 (both inclusive) with minimum weight of 50 kg.
- •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.
- •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.
- •Hemoglobin: ≥12.0 gm%.
- •Subjects without any evidence of impaired glucose tolerance in 2 hour Oral Glucose Tolerance Test (OGTT) at screening.
- •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).
- •Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire procedure.
- •Negative breath alcohol test at every check-in.
- •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
- •History / evidence of allergy or hypersensitivity to any drug
- •Any major illness in the last three months or any significant ongoing chronic medical illness
- •Recent history or presence of active kidney or liver dysfunction.
- •Active deep vein thrombosis, pulmonary embolism, arterial thromboembolic disorders or a history of these conditions.
- •History of or current gastrointestinal diseases influencing drug absorption
- •History of drug abuse (including barbiturates, benzodiazepines, opioids, cocaine, cannabinoids and amphetamine etc.) within last 3 months.
- •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).
- •History of diabetic ketoacidosis.
- •History of hypoglycaemia (symptoms include low pulse rate, watering of extremities, dizziness, weakness and sometimes fainting).
- •A history of neuropsychiatric diseases.
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the start of the study.
- •History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
- •History or presence of cancer.
- •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.
- •Consumption of grapefruit, grapefruit juice/ products and poppy-containing food and beverages within at least 48.00 hours prior to every check-in.
- •History of difficulty with donating blood or difficulty in accessibility ofveins in left or right arm.
- •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 screening (more than 100 ml within 30 days; more than 200 ml within 60 days) prior to first dose of the study or have received a known investigational drug within five elimination half-lives of the administered drug prior to the first dose of the study drug.
- •Use of any prescription drug therapy within two weeks and overthe- counter (OTC) drugs or herbal products within one week prior to receiving the dose of study medication and during the study [these include thiazolidinediones, oral hypoglycaemic agents (OHAs), monoamine oxidase inhibitors (MAOIs), non-selective betaadrenergic blocking agents, angiotensin converting enzyme (ACE) inhibitors,salicylates, anabolic steroids (except danazol and oxymetholone), alpha-adrenergic blocking agents, quinine,quinidine, sulphonamides, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone, diazoxide, asparaginase, nicotinic acid, oxymetholone, danazol, beta blockers, octreotide and lanreotide].
排除标准
- •Inclusion Criteria
- •Willingness to provide informed consent to participate in the study.
- •Body Mass Index (BMI) between 18.0 kg/m2 to 27.0 kg/m2 (both inclusive) with minimum weight of 50 kg.
- •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.
- •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.
- •Hemoglobin: ≥12.0 gm%.
- •Subjects without any evidence of impaired glucose tolerance in 2 hour Oral Glucose Tolerance Test (OGTT) at screening.
- •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).
- •Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire procedure.
- •Negative breath alcohol test at every check-in.
- •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
- •History / evidence of allergy or hypersensitivity to any drug
- •Any major illness in the last three months or any significant ongoing chronic medical illness
- •Recent history or presence of active kidney or liver dysfunction.
- •Active deep vein thrombosis, pulmonary embolism, arterial thromboembolic disorders or a history of these conditions.
- •History of or current gastrointestinal diseases influencing drug absorption
- •History of drug abuse (including barbiturates, benzodiazepines, opioids, cocaine, cannabinoids and amphetamine etc.) within last 3 months.
- •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).
- •History of diabetic ketoacidosis.
- •History of hypoglycaemia (symptoms include low pulse rate, watering of extremities, dizziness, weakness and sometimes fainting).
- •A history of neuropsychiatric diseases.
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the start of the study.
- •History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
- •History or presence of cancer.
- •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.
- •Consumption of grapefruit, grapefruit juice/ products and poppy-containing food and beverages within at least 48.00 hours prior to every check-in.
- •History of difficulty with donating blood or difficulty in accessibility ofveins in left or right arm.
- •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 screening (more than 100 ml within 30 days; more than 200 ml within 60 days) prior to first dose of the study or have received a known investigational drug within five elimination half-lives of the administered drug prior to the first dose of the study drug.
- •Use of any prescription drug therapy within two weeks and overthe- counter (OTC) drugs or herbal products within one week prior to receiving the dose of study medication and during the study [these include thiazolidinediones, oral hypoglycaemic agents (OHAs), monoamine oxidase inhibitors (MAOIs), non-selective betaadrenergic blocking agents, angiotensin converting enzyme (ACE) inhibitors,salicylates, anabolic steroids (except danazol and oxymetholone), alpha-adrenergic blocking agents, quinine,quinidine, sulphonamides, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone, diazoxide, asparaginase, nicotinic acid, oxymetholone, danazol, beta blockers, octreotide and lanreotide].
- •Cardiovascular, pulmonary, hepatic, renal, hematological, endocrinal, gastrointestinal, immunologic, dermatologic, neurological or psychiatric disease.
- •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
- •Use of drugs which may potentiate the release of neutrophils‚ such as lithium‚ in the previous 30 days before the study.
- •Female subjects who are currently breast feeding or pregnant or post menopausal (by history or as evidenced by hormonal results).
结局指标
主要结局
To demonstrate equivalence of PK and PD characteristics of G-CSF of Biogenomics and Neupogen® after multiple SC injections in healthy adult human volunteers.
时间窗: PK-18 | PD ANC-16 and CD34-5
次要结局
- To compare the safety profile and local tolerance of G-CSF of BGL and Neupogen® after multiple SC injections in healthy adult human volunteers(Throughout the study)
研究者
研究点 (1)
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