Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
Group A:Theophylline Extended-release Tablets (Theophylline 300 mg/Tablet) (Vickmans Laboratories Ltd., Hong Kong) versus Theophylline Extended-release Tablets (Theophylline 300 mg/Tablet) (AdcockIngr
Group B:Theophylline Extended-release Tablets (Theophylline 300 mg/Tablet) (AdcockIngram Limited, India) versus Theophylline Extended-release Tablets (Theophylline 300 mg/Tablet) (Vickmans Laboratorie
Sponsors
Xiangya Boai Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Healthy and non-smoking male or female, aged 18 to 55 years, including boundary values; 2)Male body weight >= 50 kg, female weight >= 45 kg, body mass index (BMI) between 19 and 26 kg / m2 (BMI = weight (kg) / height 2 (m2)), including the boundary value; 3) People who voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1) History or at present suffering from any serious clinical disease, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system(asthma, acute bronchospasm, etc), hematology, immunology, psychiatry and metabolic disorders; 2) Subjects with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, diverticulitis, enteritis, active gastrointestinal bleeding, gastrointestinal perforation or gastrointestinal surgery within 3 years; 3) Subjects who allergy to the drug (Theophylline, other xanthine derivatives or any substance in this preparation), food or other substances; 4) Subjects who have had an surgical procedure during 4 weeks before the study or planned surgery during the study; 5) Treatment of any medicine (including Chinese herbal medicine and health products) within 14 days before the study; 6) Treatment of any drug that inhibited or induced the metabolism of the liver (such as the inducer-barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole, inhibitor -SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazole, sedative hypnotics, and verapami, fluoroquinolones, antihistamine), any nitrate esters, alpha blocker drugs, PDE5 inhibitors and endothelin receptor antagonists 30 days before the study; 7) Subjects who vaccinated within 30 days before the study, or planned to vaccinate during the study or 3 months after the study; 8) Subjects who took part in any other clinical trial within 3 months before the study; 9) Subjects who donated blood or had the frequency of blood loss of > 200 mL within 3 months before the study; 10) Subjects who are unable to take one or more contraceptive measures before the 2 weeks of study, during the trial and 6 months after the trial, and who are pregnancy, sperm donation and egg donation planners; 11) Subjects who have special requirements for diet, and can not comply with a unified diet; 12) Subjects drink excessive amounts of tea, coffee and / or beverages with caffeine or xanthine (8 cups or more, 1 cups =250 mL) per day, and do not agree to stop drinking during the study; 13) Smokers or those who smoke more than 5 cigarettes per day, and do not agree to stop smokeing during the study; 14) Drinkers or those who drink frequently 6 months before the study, that is, drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of alcohol with 40% of alcohol or 150 mL of wine), and do not agree to stop drinking during the study; 15) Drug abusers or those who used soft drugs (such as cannabis) 3 months before the start of study or those who took hard drugs (such as cocaine, phencyclidine, etc.) 1 years before the start of study; 16) Subject with vasovagal syncope, poor venous and vascular conditions or difficult puncture; 17) Positive results of tobacco screening; 18) Subjects with poor compliance or other reasons that prevent the volunteers from finishing the study, or those considered not to be recruited by the researchers; 19) Subjects with abnormal in vital signs are of clinical significance (according to the physician's judgment); 20) Subjects with abnormal in electrocardiogram and laboratory examination are of clinical significance (according to the physician's judgment); 21) Women during pregnancy and lactation; 22) Subjects with abnormal in blood pregnancy (beta-HCG) are of clinical significance (female subjects only); 23) Subjects with abnorma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactZhang Bikui
Xiangya Bo'ai Rehabilitation Hospital
Outcome results
None listed