Pharmacokinetics and Pharmacodynamics of Higenamine in Ch... | NCT01451229

NCT01451229

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Eligibility Module

Eligibility Criteria

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).](streamdown:incomplete-link)