Hypertension
Conditions
Interventions
A:fasting adminstration of a branded formulation (reference) and then amlodipine besylate 5mg-the generic formulation (test)
B:fasting adminstration of amlodipine besylate 5mg-the generic formulation (test) and then a branded formulation (reference)
C:a branded formulation (reference) and then amlodipine besylate 5mg-the generic formulation (test) after eating
D:amlodipine besylate 5mg-the generic formulation (test) and then a branded formulation (reference) after eating
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 45 years old (including 18 and 45 one full year of life), both men and women, single gender not less than one-third of the total; 2) Male subjects with weight more than 50 kg (contain 50 kg), female subjects with weight more than 45 kg (including 45 kg); Body mass index [BMI = weight (kg)/height (m) 2] within the scope of the 19 ~ 28 kg/m2; 3) According to past medical history, comprehensive physical examination and laboratory test, the researchers identified as healthy subjects; 4) Fertile woman should have negative pregnancy blood test ,and should take effective appropriate precautions from 14 days before the delivery to 6 months after the study. 5) Male should take effective appropriate precautions from 14 days before the delivery to 6 months after the study,and agree not to participate in sperm donation during the period. 6) Subject should have a strong understand of the object, nature and eventuality of trial, volunteer for the trial and sign the informed consent. 7) Subjects Can communicate well with the researchers and comply with the requirements of the entire study, and would like to check in phase I clinical research unit in accordance with the relevant provisions.
Exclusion criteria
Exclusion criteria: 1) Subject can't tolerate venipuncture; 2) Allergic constitution: the persons allergic to two or more medicines, food and pollen or ingredients of investigator product; 3) Any medical history of cardiovascular, hepatic, kidney, gastrointestinal tract, and nervous system, metabolic disturbance, etc. 4) Laboratory test (hematology, urine analysis, blood biochemistry, ECG examination ) results judged as clinical significance of abnormal; 5) Hematology screening for HIV antibodies or HBV surface antigen or HCV antibody or TP antibody positive; 6) Women who are pregnant, pregnant, or plan to become pregnant in the near future; 7) The pregnancy test positive; 8) Male subjects did not take effective contraceptive measures or their spouse planned to conceive in the next six months; 9) Mental or legal disability; 10) History of prescription drug abuse and / or illicit drug abuse in the past 6 months; within 6 months prior to screening has a history of alcohol abuse, that drinking more than 14 units of alcohol a week (1 = 12 ounces or 360 mL beer, 1.5 ounces or 45 mL liquor alcohol content of 40%, 5 oz or 150 mL wine); 12) within 6 months prior to screening smoking more than five cigarettes a day; 13) drug abuse or alcohol test positive; 14) Subjects have a history of hospitalization or surgery within 3 months before screening history (except appendicitis); 15) Participating in other clinical trials within the past 3 months; 16) Blood donation or a history of acute blood loss (more than 400 mL) or 1 months after the end of the test plan to blood donors; 17) use any other drugs within 2 weeks before the trial;; 18) Subjects who drink strong tea, coffee and/or caffeinated drinks more than 1 l every day; 19) Subjects cannot understand the content of the informed consent and other do not accord with standard of trial; 20) Unsuitable to participate in the trial considered by the researchers (such as weak, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUCinf; | — |
Contacts
Public ContactLiu Jian
Outcome results
None listed