COPD
Conditions
Interventions
Group I (Healthy Chinese subjects):Roflumilast
Group II (Healthy Caucasian subjects):Roflumilast
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese and Caucasian males aged 18–65 years (inclusive) at the screening visit. Caucasian subjects are individuals whose biological parents, grandparents, and great-grandparents are all Caucasians; 2. Body weight >= 50.0 kg, body mass index (BMI) 19.0–28.0 kg/m2 (inclusive); 3. Subjects who fully understand the objectives, nature, methods, and possible adverse reactions of this trial, voluntarily participate in this trial and sign the informed consent form; 4. Subjects who are able to adhere to the study protocol and complete the trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with any history of severe clinical illnesses, such as blood, circulatory, digestive, urinary, respiratory, nervous, immune, endocrine, mental (including insomnia, anxiety, depression, and suicidal thoughts) and metabolic disorders as well as malignancies, or any other illness or physiological conditions that may interfere with the trial results; 2. Abnormalities in vital signs, physical examination, 12-lead ECG or laboratory tests (including hematology, urinalysis, and blood biochemistry) during the screening period that are judged to be clinically significant by the investigator; 3. Subjects with dysphagia or a difficult blood draw; 4. History of fainting at the sight of needle or blood or known tendency of severe bleeding; 5. History of allergy or known allergy to roflumilast and its excipients; 6. History of drug abuse within the past 2 years (including the use of prohibited substances for medical use and controlled drugs); 7. Positive for drug abuse screening (including benzodiazepines, methamphetamines, cocaine, morphine, ketamine, and tetrahydrocannabinol); 8. Subjects who require special diet and cannot follow a uniform diet; 9. Unable to cease consumption of chocolate or any foods or drinks (e.g., passion fruit, pomelo, grapefruit, orange or mango) that contain caffeine or may affect the trial results at 48 h before dosing and during the trial; 10. Use of any agent (e.g. inducers: Rifampicin, barbiturates, carbamazepine, phenytoin, glucocorticoids or omeprazole; inhibitors: SSRI antidepressants, cimetidine, diltiazem, macrolides or nitroimidazoles) that inhibits or induces drug metabolism by the liver within 28 days before administration of the investigational drug; 11. Use of any prescription or non-prescription drugs and any functional vitamins or Chinese herbal products within 14 days before screening; 12. Subjects who underwent surgery within 3 months before screening or plan to undergo surgery during the trial and those who underwent surgeries that impact drug absorption, distribution, metabolism, and excretion; 13. Consumed over 5 cigarettes daily within 3 months before the trial or unable to quit smoking during the trial; 14. Consumed a weekly mean of 14 units of alcohol (1 unit ˜ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) within 3 months prior to screening or positive for the alcohol test; 15. Participated in any clinical trial within 3 months prior to screening; 16. Donated or lost >= 400 mL of blood within 3 months prior to screening; 17. Positive for HIV, treponema pallidum antibody, hepatitis B surface antigen or hepatitis C virus antibody; 18. Subjects who received vaccination within 3 months prior to screening or plan to receive vaccination during the trial; 19. Subjects (or their partners) who are planning to bear a child or donate sperm or are reluctant to take one or more physical contraceptives during the trial and within 3 months after administration; 20. Subjects who are judged to be unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactLi Jintong
China-Japan Friendship Hospital
Outcome results
None listed