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临床试验/CTRI/2015/02/005507
CTRI/2015/02/005507招募中未知

A randomized, double-blind, two-treatment, single-period, parallel design study to compare the pharmacokinetics and pharmacodynamics (PK/PD) of R-TPR-029 (test pegfilgrastim) 6 mg/0.6 mL of Reliance Life Sciences Pvt. Ltd., India with Neulasta® (reference pegfilgrastim) of Amgen Europe BV, the Netherlands in healthy, adult, human subjects following subcutaneous administration under fasting condition.

Reliance Life Sciences Pvt Ltd0 个研究点目标入组 70 人开始时间: 待定最近更新:
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试验速览

阶段
未知
状态
招募中
入组人数
70
研究概览入排标准研究者记录与标识符相似试验

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 adult male and female subjects, aged between 18 to 45 years (both inclusive).
  • •2.Subjects with Body Mass Index (BMI) 18 to 24.9 kg/m2
  • •3.If subject is a female and is
  • •-of child bearing potential, she should be practicing an acceptable method of birth control for the duration of the study as judged by the investigator, such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence
  • •- surgically sterile, bilateral tubal ligation should be documented
  • •4. Subjects able and willing to comply with the protocol requirements.
  • •5.Subjects willing to voluntarily provide written informed consent.
  • •6.Subjects willing to undergo pre- and post-study physical examinations and laboratory
  • •7.Subjects who are non-smokers based on history.
  • •8. Subjects willing to adhere to the protocol and the following study requirements:
  • •Should not consume xanthine containing products, such as coffee, tea, chocolate or soft drinks at least 48 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) until the last sample collection.
  • •Should not consume alcohol at least 48 hours prior to dosing (i.e. during in-house monitoring and the remaining based on history) until the last sample collection.
  • •Should not consume grapefruit or its products at least 7 days prior to dosing (i.e. during in-house monitoring and the remaining based on history) and until the last sample collection.
  • •9. Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments, ECG, chest X Ray or vital signs.

排除标准

  • •Inclusion Criteria
  • •1.Healthy adult male and female subjects, aged between 18 to 45 years (both inclusive).
  • •2.Subjects with Body Mass Index (BMI) 18 to 24.9 kg/m2
  • •3.If subject is a female and is
  • •-of child bearing potential, she should be practicing an acceptable method of birth control for the duration of the study as judged by the investigator, such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence
  • •- surgically sterile, bilateral tubal ligation should be documented
  • •4. Subjects able and willing to comply with the protocol requirements.
  • •5.Subjects willing to voluntarily provide written informed consent.
  • •6.Subjects willing to undergo pre- and post-study physical examinations and laboratory
  • •7.Subjects who are non-smokers based on history.
  • •8. Subjects willing to adhere to the protocol and the following study requirements:
  • •Should not consume xanthine containing products, such as coffee, tea, chocolate or soft drinks at least 48 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) until the last sample collection.
  • •Should not consume alcohol at least 48 hours prior to dosing (i.e. during in-house monitoring and the remaining based on history) until the last sample collection.
  • •Should not consume grapefruit or its products at least 7 days prior to dosing (i.e. during in-house monitoring and the remaining based on history) and until the last sample collection.
  • •9. Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments, ECG, chest X Ray or vital signs.
  • •Exclusion Criteria (Any of the following)
  • •1. Subjects incapable of understanding the informed consent process.
  • •2. Pregnant female subjects with a positive pregnancy test at screening or positive serum β-HCG test or lactating females.
  • •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 administration of study medication until the post-study follow-up (i.e. until 56 days from the drug administration). 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), 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), oral temperature ( 95.60F or 990F) 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 with any evidence of organ dysfunction or any clinically significant
  • •deviation from normal in their physical or clinical evaluation including ECG and X ray results.
  • •8.Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within 30 days prior to the start of the c

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