Pharmacokinetics and Pharmacodynamics of Higenamine in Chinese Healthy Subjects

Overview

The purpose of this study is to assess the pharmacokinetics and pharmacodynamics of higenamine in healthy Chinese subjects

Full Title of Study: “An Open-Label, Single-dose Administration Study of the Pharmacokinetics and Pharmacodynamics of Higenamine, Administered Intravenously Injection to Healthy Chinese Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2009

Interventions

  • Drug: higenamine
    • infused intravenously with higenamine at the escalating doses from 0.5 ug/kg/min through 1.0 ug/kg/min and 2.0 ug/kg/min to 4.0 ug/kg/min, each dose being given for 3 minutes

Clinical Trial Outcome Measures

Primary Measures

  • The maximum observed plasma concentration
    • Time Frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
  • area under the concentration-time curve
    • Time Frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
  • clearance
    • Time Frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
  • volume of distribution
    • Time Frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
  • terminal half-life
    • Time Frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
  • amount excreted in urine
    • Time Frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
  • renal clearance
    • Time Frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
  • heart rate
    • Time Frame: predose and at 2, 5, 8, 11, 13, 15, 17, 27 and 42 minutes postdose

Participating in This Clinical Trial

Inclusion Criteria

Subjects must meet all the following inclusion criteria to be eligible to participate in this study: 1. Chinese healthy adult males, female subjects (either gender the proportion of not less than 1 / 3). 2. Age: 19 to 45 (including 19, 45) years old. 3. Male body weight ≥ 50kg, female body weight ≥ 45kg, and body mass index within the normal range (weight (kg) / height 2 (m2) = 18-25). 4. Informed consent form is obtained. Exclusion Criteria:

Subjects will be excluded from entry if any of the criteria listed below are met: 1. Presence or history of any disorder of cardiovascular system, respiratory system, digestive system, urogenital system, endocrine system, allergy / immune system, blood system, nervous / mental system, musculoskeletal system, skin diseases. 2. History of any drug hypersensitivity. 3. Female urine pregnancy test was positive. 4. Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and/or hepatitis C virus (HCV) antibodies. 5. Acute disease state or infection associated with prescription drugs within 1 month before study day 1. 6. Taking any drugs, including over-the-counter drugs and herbal supplements within 7 days before study day 1. 7. History of alcohol abuse (consuming greater than 14 glasses of alcoholic beverages each week, 1 glass is approximately equivalent to: beer 284 mL, wine 125 mL, or distilled spirits [25 mL). 8. History of drug abuse. 9. Smoker or subjects quitting smoking less than 1 month before study day 1. 10. Participating other trials within 1 month before study day 1. 11. Donating blood (> 400 mL) within 1 month before study day 1. 12. During screening, alcohol breath test result > 0.000. 13. Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg. 14. Heart rate was lower than 45 beats per minute (bpm) and/or higher than 90 bpm during rest. 15. The investigator thought the subjects might not be able to complete the study or comply with the requirements of the study (due to management reasons or other reasons).

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Peking Union Medical College Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ji Jiang, 88068357, Principal Investigator, Chinese Academy of Medical Sciences

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