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Completed

NCT Number: NCT01451229

Pharmacokinetics and Pharmacodynamics of Higenamine in Chinese Healthy Subjects

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

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet all the following inclusion criteria to be eligible to participate in this study:

  • Chinese healthy adult males, female subjects (either gender the proportion of not less than 1 / 3).
  • Age: 19 to 45 (including 19, 45) years old.
  • Male body weight ≥ 50kg, female body weight ≥ 45kg, and body mass index within the normal range (weight (kg) / height 2 (m2) = 18-25).
  • Informed consent form is obtained.

Exclusion criteria

Subjects will be excluded from entry if any of the criteria listed below are met:

  • 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.
  • History of any drug hypersensitivity.
  • Female urine pregnancy test was positive.
  • 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.
  • Acute disease state or infection associated with prescription drugs within 1 month before study day 1.
  • Taking any drugs, including over-the-counter drugs and herbal supplements within 7 days before study day 1.
  • 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).
  • History of drug abuse.
  • Smoker or subjects quitting smoking less than 1 month before study day 1.
  • Participating other trials within 1 month before study day 1.
  • Donating blood (> 400 mL) within 1 month before study day 1.
  • During screening, alcohol breath test result > 0.000.
  • Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.
  • Heart rate was lower than 45 beats per minute (bpm) and/or higher than 90 bpm during rest.
  • 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).

Treatment and study plan

higenamine

Drug

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

Primary outcomes

  1. The maximum observed plasma concentration

    Time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose

  2. 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

  3. clearance

    Time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose

  4. volume of distribution

    Time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose

  5. terminal half-life

    Time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose

  6. amount excreted in urine

    Time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose

  7. renal clearance

    Time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose

  8. heart rate

    Time frame: predose and at 2, 5, 8, 11, 13, 15, 17, 27 and 42 minutes postdose

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 13, 2011
Registry last updated
Oct 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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