Disease of respiratory system
Conditions
Interventions
Group A:Take the test preparation before taking the reference preparation under fasting conditions
Group B:Take the reference preparation before taking the test preparation under fasting conditions
Group C:Take the test preparation before taking the reference preparation under postprandial conditions
Group D:ake the reference preparation before taking the test preparation under postprandial conditions
Sponsors
Deyang People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age and gender: healthy male and female subjects over 18 years old (including 18 years old); 2. Body mass index: male weight >= 50.0 kg, female weight >= 45.0 kg, 19.0 kg/m2 <= body mass index <= 26.0 kg/m2. BMI = weight/height2 (kg/m2); 3. Have a full understanding of the test content, test drugs, test process, etc., be able to communicate well with the researchers, be able to complete the study in accordance with the research regulations, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. (Interview during the screening period) Those who have a history of severe allergies (such as angioedema and anaphylactic shock), allergic constitution (such as those who are allergic to pollen, two or more drugs/food) or known to be allergic to the components of this drug and those who are allergic to excipients; 2. (Screening period/admission consultation) Previous history of major diseases such as cardiovascular, liver and gallbladder, kidney, endocrine, digestive tract, blood system, respiratory system, immune system, mental abnormalities, metabolic disorders, and benign/malignant tumors or existing Those with the above diseases, or those with other diseases that current researchers believe are not suitable for participating in clinical trials; 3. (Screening period/Admission consultation) Those who have undergone major surgical operations within six months before the trial screening or those who have undergone operations that may significantly affect the in vivo process or safety evaluation of the study drug (for example: liver, gallbladder, kidney or gastrointestinal surgery) partial tract resection, brain or spine or ophthalmic surgery, except appendectomy, hernia repair, circumcision), or those who plan to undergo surgery during the trial period; 4. (Screening period/admission consultation) within 3 months before the first administration of the trial, a large amount (more than 400mL) of blood donation/blood loss (except for female physiological blood loss) or receiving blood transfusion or using blood products, or planning to be in the trial period and the last time Those who donate blood or blood components within 1 month after administration; 5. (Screening period/Admission consultation) Those who have participated in any clinical trial and taken medicine within 90 days before the first dose of the trial, or plan to participate in other clinical trials during this study; 6. (Screening period/Admission consultation) Those who have used any drug that interacts with montelukast sodium or affects its bioavailability within 30 days before the first dose of the trial (such as inhibiting or inducing the liver to metabolize the drug) Drugs used: Inducers - barbiturates, carbamazepine, phenytoin, corticosteroids, omeprazole; Inhibitors - ketoconazole, itraconazole, cimetidine, diltiazem, macrolides , nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, etc.), or those who have used drugs with a long half-life; 7. (Screening period/check-in consultation) Those who have used any prescription drugs, non-prescription drugs, Chinese herbal medicines and health care products for various reasons within 14 days before the first administration of the test, or those who plan to use the above drugs and health care products during the test period; 8. (Screening period/check-in consultation) Those who have been vaccinated within 14 days before the first dose of the trial, or those who plan to be vaccinated during the trial; 9. (Interview during the screening period) Those who have a history of drug abuse or drug dependence in the past; 10. (Screening period/check-in consultation) Former smokers or those who smoked more than 5 cigarettes per day on average within 3 months before screening, or who could not stop using any tobacco products (including nicotine products) during the entire trial period; 11. (Screening period/check-in consultation) Former alcoholics/alcoholics (that is, men drink more than 28 standard units p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| peak concentration;area under the plasma concentration-time curve;Area under the plasma concentration-time curve extrapolated to infinity; | — |
Secondary
| Measure | Time frame |
|---|---|
| peak time;apparent terminal elimination half-life; | — |
Countries
China
Contacts
Public ContactHan Yangyun
Deyang People's Hospital
Outcome results
None listed