Bioequivalence Study of Two Roxithromycin Tablets in Healthy Subjects

Inclusion criteria

• Chinese healthy adults over 18 years old ( including 18 years old ) ;
• Weight : male ≥ 50.0kg, female ≥ 45.0kg and body mass index ( BMI ) :

19.0 ~ 26.0kg / m2 ( including boundary value, BMI = weight ( kg ) / height ( m ) 2 ) ;

• Understand and sign the informed consent, volunteer to participate in this study ;
• Be able to communicate well with the researchers and complete the study in accordance with the provisions of the study.

Exclusion criteria

• There is a history of diseases such as cardiovascular system, respiratory system, digestive system, endocrine system, nervous / mental system, blood and lymphatic system, skeletal muscle system, family genetic disease history and so on;
• Patients who had undergone major surgery within 1 year before screening and were judged not suitable for enrollment by the researchers;
• Comprehensive physical examination, vital signs, 12-lead electrocardiogram, laboratory tests [ including blood routine, urine routine, blood biochemistry, coagulation function, blood pregnancy ( only female subjects ) ], etc., suggested that there were abnormalities judged by the researchers as clinically significant ;
• electrolyte potassium < 3.5mmol / L or magnesium < 0.75mmol / L in blood biochemistry ;
• hepatitis B surface antigen ( HBsAg ), hepatitis B e antigen ( HBeAg ), hepatitis C antibody ( HCV-Ab ), human immunodeficiency virus antibody ( HIV-Ab ), treponema pallidum antibody ( TP-Ab ) any test results positive ;
• the existence of researchers judged to have clinical significance of food, drug allergy or other allergic disease history ( asthma, urticaria, eczematous dermatitis, etc. ) or the product and its excipients or its analogues allergy ;
• Patients who used any drugs that interact with roxithromycin within 30 days before screening ( such as contraceptives, ergotamine/dihydroergotamine, theophylline, anticoagulants, digoxin and other cardiac glycosides, midazolam, cyclosporine, drugs that can prolong QT interval [antidepressants ( such as citalopram ), antiarrhythmic drugs ( such as sotalol, amiodarone ), cisapride, antipsychotics ( such as clozapine

• antibiotics ( such as erythromycin ) ] ;
• who had used any drug within 2 weeks before screening, and was judged by the researcher to be likely to affect the evaluation results of this study ;
• Patients with a history of drug abuse / drug dependence or positive urine screening within 12 months before screening ;
• Patients who drank more than 14g alcohol per week ( 1 unit = 360ml beer or 45ml alcohol with 40 % alcohol or 150ml wine ) within 6 months before screening, or who could not give up drinking during the trial, or who were positive for alcohol breath test ;
• patients who had long-term excessive drinking ( more than 8 cups a day, 1 cup = 250ml ) of tea, coffee or caffeine-containing beverages ;
• Smoking ≥ 3 cigarettes per day within 3 months before screening or those who could not guarantee to give up smoking during the trial ;
• Patients who participated in other drug clinical trials and took research drugs within 3 months before screening ( the last visit time of the last trial was calculated as the start time ) ;
• Screening for blood donation or blood products or massive bleeding > 200ml or 1 unit within the first 3 months, or planning to donate blood or blood components during the study period ;
• Do not agree to avoid the use of tobacco ( including any nicotine-containing smoking cessation products such as nicotine lozenges, nicotine gum ), wine or xanthine, grapefruit, caffeine ( such as coffee, strong tea, chocolate, etc. ) drinks or food ( such as animal liver, mango, pitaya, etc. ), or to avoid strenuous exercise, or to avoid other factors affecting drug absorption, distribution, metabolism, excretion, etc. ;
• Pregnant or lactating women, or those with positive pregnancy test results before the test ; male subjects or female subjects were unwilling to take one or more non-drug contraceptive measures ( such as complete abstinence, contraceptive ring, partner ligation, etc. ) during the trial, or had sperm / egg donation plans or male subjects ( or their partners ), female subjects had fertility plans ( from the signing of informed consent to 3 months after the last administration ) ;
• patients with difficulty in venous blood collection or fainting ;
• tablet swallowing difficulties ;
• those who have special requirements for diet, cannot abide by the diet provided and the corresponding regulations ;
• Subjects who were considered inappropriate to participate in this clinical study.