Idiopathic pulmonary fibrosis
Conditions
Interventions
drug interaction study:D1 to D2: 40mg omeprazole enteric coated capsules orally on an empty stomach
400mg TDI01 suspension orally on an empty stomach from D3 to D7
and 40mg omeprazole enteric coated capsules and 400mg TDI01 suspension orally on an empty stomach at D7
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Male or female, non-smoker (no use of tobacco or nicotine products in the 3 months prior to screening), age =18 years and =65 years, BMI>18.5 kg/m2 and <26 kg/m2, weight not less than 50.0 kg for males and 45.0kg for females. 2) Health was defined as: a) no clinically significant disease or surgery during the 4 weeks prior to administration. Subjects in the first study who vomited within 24 hours prior to administration of the drug will be carefully evaluated for impending disease. It was at the discretion of the investigator whether to be selected before administration. b) No history or condition of clinically significant neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, liver, or metabolic diseases. c) Chest X-ray examination showed no clinically significant abnormalities. 3) Fertile women who have active sex with a non-sterilized male partner (a sterilized male partner is defined as a man who has had a vasectomy for at least 6 months) must be willing to use one of the following acceptable contraceptive methods throughout the study period and (the last time, if applicable) for 30 days after study drug administration: a) To study (for the first time) the placement of an IUD without a hormone-releasing system at least 4 weeks prior to drug administration, while the male partner uses a condom; b) The use of a contraceptive diaphragm or cervical cap with an intravaginal spermicide and a male condom for the male partner at least 21 days prior to the administration of the study drug (final, if applicable). 4) Male subjects who have had an active sexual life with a fertile female partner (a fertile female is defined as a female who is neither postmenopausal nor surgically sterilized) less than 6 months after their vasectomy must be willing to use one of the following acceptable contraceptive methods for at least 90 days from (first) study drug administration to (last, if applicable) study drug administration: a) The use of a male condom and the initiation of hormonal contraceptives or the placement of an IUD by the female partner at least 4 weeks prior to administration; b) Use a male condom while the female partner uses a contraceptive diaphragm or cervical cap with an intravaginal spermicide. 5) Male subjects with a pregnant partner (including men who underwent a vasectomy) must consent to condom use for at least 90 days from (first) study drug administration to (last, if applicable) study drug administration. 6) Male subjects must agree not to donate sperm until 90 days after the study drug (final dose, if applicable) is administered. 7) Before the test, understand the nature, significance, possible benefits, possible inconvenience and potential dangers of the test in detail, understand the research procedure and sign the informed consent in person voluntarily.
Exclusion criteria
Exclusion criteria: 1) Clinically significant physical abnormalities, clinically significant laboratory results, or positive results for hepatitis B, hepatitis C, syphilis, or HIV detected during medical screening. 2) Clinically significant evidence of liver or kidney damage, including but not limited to alanine aminotransferase (ALT) and aspartate aminotransferase (AST) above ULN (the upper limit of normal), total bilirubin above ULN, gamma-glutamyl transpeptidase above ULN, or creatinine above ULN. 3) History of allergic reaction to the test drug and any of its components, similar drugs of the test drug or to any excipients in the preparation. (e.g., rapid allergic reactions, significant respiratory and skin symptoms) or a history of hypersensitivity. 4) A history of clinically significant gastrointestinal disease or surgery that may interfere with drug absorption. Gastrointestinal disease causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome, 5) or a history of severe vomiting and diarrhea within one week prior to enrollment; 6) Subjects who have positive pregnancy tests during the screening period, are pregnant or lactating women, and female subjects of childbearing age who cannot take contraception as required; 7) History of clinically significant prolonged QTc interval, or QTc interval > 470ms for women and >450ms for men during the screening period. 8) Clinically significant abnormalities in vital signs during the screening period (systolic blood pressure below 90 or more than 140mmHg, diastolic depression at 50 or more than 90 MMHG, or heart rate less than 50 or more than 100bpm). 9) A history of severe alcohol abuse in the year prior to screening or regular alcohol consumption (more than 14 units per week [1 unit =150mL wine, 360mL beer, or 45mL 40% alcohol] in the 6 months prior to screening interview) and a positive alcohol breath test. 10) had a history of serious substance abuse or positive urine screening in the year prior to screening, or had used soft drugs (e.g., marijuana) in the three months prior to screening, or had used hard drugs (e.g., cocaine, PCP [PCP], crack [crack], opioid derivatives, including heroin and amphetamine derivatives) within the year prior to screening. 11) Frequent use of sedatives, sleeping pills or other addictive drugs in the 6 months prior to enrollment12)Participate in a clinical study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing, receive dosing of a biological product within the context of a clinical study within 90 days prior to dosing, or concurrently participate in an investigational study that does not involve the administration of a drug or device. 13) Use of drugs within the time frame specified below, except for drugs exempt by the investigator on a case-by-case basis because they are judged to be unlikely to affect PK characteristics or subject safety of the study drug (e.g., topical preparations without significant systemic absorption) : a) (for the first time, if applicable) use of prescription drugs within 14 days prior to administration, especially proton pump inhibitors (PPI) (e.g. Rabeprazole, Pantoprazole, omeprazole enteric capsules, etc.); b) Use of over-the-counter and natural health products (including Chinese herbs, homeopathic and traditional medicines, probiotics, vitamin, mineral, amino acid, essential fatty acid and other food supplements, protein supplements for exercise), e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;blood routine;Blood biochemistry;Coagulation;ECG;Urine routine;Physical examination;vital signs;Blood pregnancy test; | — |
Countries
China
Contacts
Public ContactYun Cai
Chinese PLA General Hospital
Outcome results
None listed