Pharmacokinetics and Pharmacodynamics of Higenamine in Chinese Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01451229
First received: October 11, 2011
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: higenamine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single-dose Administration Study of the Pharmacokinetics and Pharmacodynamics of Higenamine, Administered Intravenously Injection to Healthy Chinese Subjects

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • clearance [ Time Frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose ] [ Designated as safety issue: No ]
  • volume of distribution [ Time Frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose ] [ Designated as safety issue: No ]
  • terminal half-life [ Time Frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose ] [ Designated as safety issue: No ]
  • amount excreted in urine [ Time Frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose ] [ Designated as safety issue: No ]
  • renal clearance [ Time Frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose ] [ Designated as safety issue: No ]
  • heart rate [ Time Frame: predose and at 2, 5, 8, 11, 13, 15, 17, 27 and 42 minutes postdose ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451229

Locations
China
Peking Union Medical College
Beijing, China
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Ji Jiang, 88068357 Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01451229     History of Changes
Other Study ID Numbers: 2009-PK003
Study First Received: October 11, 2011
Last Updated: October 12, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Peking Union Medical College Hospital:
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:
Higenamine
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-Agonists
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiotonic Agents
Cardiovascular Agents
Central Nervous System Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014