Bioavailability Comparison Study of Two Types of Nimodipine Injections in Healthy Volunteers
Bioavailability Comparison Study of Two Types of Nimodipine Injections in Healthy Volunteers
A Randomized, Open-label, Single Dose, Two Formulation, Two Period, Double Cross Over
 Bioavailability Comparison Study of two types of Nimodipine Injections in Healthy Volunteers.
The investigation product Nimodipine Injection (II) was supplied by Shenyang Dongxing
 Pharmaceutical Technology Co., Ltd.And Nimodipine injection (trade name: Nimotop)
 manufactured by Bayer Pharma AG was used as the reference preparation.The volunteers were
 administered with Nimodipine injection for intravenous infusion (containing nimodipine 11 mg)
 for 12 consecutive hours, respectively.The Venous blood was collected at 0 hours before the
 administration (ie, 1 hour before the administration) and 10 minutes, 20 minutes, 30 minutes,
 45 minutes, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h (Administration was over) and 12.5 h, 13
 h, 14 h, 16 h, 19 h, 22 h, 25 h, 36 h, 3 ml per blood collection.
Inclusion Criteria:

 1. Sign the informed consent form before the study, and fully understand the test
 content, process and possible adverse reactions, and be able to comply with the
 protocol according to the test plan requirements;

 2. Healthy subjects, both male and female;

 3. Age ≥ 18 years old;

 4. Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index in the range of 19 ~ 26
 (including the critical value)[Body mass index (BMI) = weight (kg) / height 2 (m2)].

 Exclusion Criteria:

 - Subject who is in one of the following conditions may not be eligible.

 1. Those who smoke more than 5 cigarettes per day for 3 months before the test or who
 cannot stop smoking during the trial period;

 2. Allergies, such as those who are allergic to drugs, food and pollen, or those known to
 be allergic to nimodipine;

 3. Those who have a history of alcohol abuse 6 months before the test (defined as
 drinking 14 units of alcohol per week: 1 unit = 285 ml of beer, or high-alcohol (50%
 or more alcohol) 25 ml, or 150 ml of wine) or Drinkers cannot be stopped during the
 trial;

 4. Donor blood or a large amount of blood loss ≥400 ml (excluding female menstrual blood
 volume) within 3 months before the test, or have a history of halo and fainting;

 5. Anyone taking any drug within 14 days before the test;

 6. Antidepressants (such as fluoxetine), nortriptyline, norfloxacin, anti-HIV drugs (such
 as azidothymidine), calcium antagonists (such as nifedipine), were used within 28 days
 prior to the test. Diltiazem, verapamil, alpha-methyldopa and other antihypertensive
 drugs;

 7. Have taken the study drug within 3 months before the test, or participated in any drug
 or medical device clinical trial;

 8. Clinical laboratory examination, vital signs, physical examination, and 12-lead ECG
 abnormalities in the screening period are clinically significant;

 9. During screening, when staying in the clinical center, the supine pressure of the
 supine position is not in the range of 100~139 mmHg, and the diastolic pressure in the
 supine position is not in the range of 60~89 mmHg;

 10. During screening, when staying in the clinical center, the pulse is not in the range
 of 60~100 beats/min before each dose;

 11. There is a serious arrhythmia: QTc interval prolongation (QTc over 450 ms), or QTc
 interval prolongation syndrome or family history of sudden death

 12. A positive result of screening for hepatitis B surface antigen, hepatitis C virus
 antibody, human immunodeficiency virus antibody or Treponema pallidum-specific
 antibody;

 13. Health status: a history of major diseases or important organ diseases such as nervous
 system, mental system, respiratory system, cardiovascular system, digestive system,
 blood system, endocrine system, musculoskeletal or metabolic abnormalities;

 14. pregnant and lactating women;

 15. Female subjects of childbearing age have a pregnancy plan or unable to take effective
 contraception after the first dose and within 3 months after the last dose, from 30
 days before screening to 3 months after the last dose. Measures (non-pharmaceutical
 contraception), see the appendix for specific contraceptive measures;

 16. Can not stop taking chocolate, any caffeinated food or drink during the test; or eat
 any food or drink containing grapefruit ingredients 14 days before the first dose to
 the end of the test;

 17. Those who are positive for alcohol screening before dosing, or who have taken any
 alcoholic products within 24 hours prior to dosing;

 18. Those who are positive for drug screening, who have had a history of drug abuse in the
 past five years or who have used drugs three months before the trial;

 19. Investigators believe that it is not appropriate to participate in this test