Pharmacokinetics and Pharmacodynamics of Higenamine in Chinese Healthy Subjects

October 12, 2011 updated by: Peking Union Medical College Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The maximum observed plasma concentration
Time Frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
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
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
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
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
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
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
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
predose and at 2, 5, 8, 11, 13, 15, 17, 27 and 42 minutes postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ji Jiang, 88068357, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2009-PK003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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