Clinical trial NCT01451229: Pharmacokinetics and Pharmacodynamics of Higenamine in Chinese Healthy Subjects
Official title: An Open-Label, Single-dose Administration Study of the Pharmacokinetics and Pharmacodynamics of Higenamine, Administered Intravenously Injection to Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
pharmacodynamics
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2011-10-13
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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).

Primary outcomes:
measure: The maximum observed plasma concentration
timeFrame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
measure: area under the concentration-time curve
timeFrame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
measure: clearance
timeFrame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
measure: volume of distribution
timeFrame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
measure: terminal half-life
timeFrame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
measure: amount excreted in urine
timeFrame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
measure: renal clearance
timeFrame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
measure: heart rate
timeFrame: predose and at 2, 5, 8, 11, 13, 15, 17, 27 and 42 minutes postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Ji Jiang, 88068357
role: PRINCIPAL_INVESTIGATOR
References: