Pharmacokinetics and Pharmacodynamics of Higenamine in Chinese Healthy Subjects

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: higenamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01451229

2009-PK003

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)