Asthma, COPD
Conditions
Interventions
Oral pharmacokinetics study group:R-BMB 5mg Q24 for 21 days
multiple oral administration of 5mg group:R-BMB 5mg QN for 28 days
multiple oral administration of 10mg group:R-BMB 10mg QN for 28 days
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Subject is a healthy adult male or a female of non-childbearing potential between the ages of 30 and 70 years, inclusive. 2. Subject has a fasting serum LDL-c level more than 4.10mmol /L, and TC level more than 5.20mmol/L. 3. Subject has fasting serum BChE activity more than 8000 U/L. 4. Subject has a meal evaluation score less than 5.
Exclusion criteria
Exclusion criteria: 1) Subject has the presence of an active or recurring clinically significant dysphagia or gastrointestinal, liver, and kidney diseases; and/or drug allergy or specific allergic reaction; and/or hyperthyroidism or hyperthyroidism requiring medical treatment. 2) Subject has any surgical or medical condition or clinically relevant abnormalities in clinical laboratory parameters that might significantly alter the absorption, distribution, metabolism, or excretion. Mild hypertension and mild fatty liver disease are permitted as judged by the investigator. 3) Subject uses any prescription or non-prescription drugs, or health products within 2 weeks prior to the start of the study; and/or addictive drugs; and/or drinks excessive amounts of tea, coffee and/or caffeinated beverages (8 or more cups) per day. 4) Subject uses lipid-lowering drugs 30 days before the starting day of the trial. 5) Subject has a TC level more than 5.6mmol/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic index; | — |
Countries
China
Contacts
Public ContactLing Guan
Dongguan People's Hospital
Outcome results
None listed