none, healthy volunteer
Conditions
Interventions
T-R:XY066 in first period, nexium in second period
R-T:nexium in first period, XY066 in second period
Sponsors
Changchun Haiyue Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1) Subjects understand the purpose, protocol and possible adverse events of the study, sign the informed consent before study; 2) Aged 18-50, male or female; 3) With a BMI of 19-26, weight >=50.0kg for male, weight >=45.0kg for female; 4) Subjects can communicate well with investigators, understand and follow the requirements.
Exclusion criteria
Exclusion criteria: 1) History of allergic to Esomeprazole Magnesium, or any drug component, or benzimidazoles, or allergic to two or more drugs and/or food; 2) Clinical significant abnormal in physical examinations, vital signs examinations, lab tests, and electrocardiogram; 3) Positive HBsAg, HCVAb, HIVAg, HIVAb, and TPHA RPR; 4) History of cardiovascular, urinary, digestive, neural, respiratory, psychiatric, metabolic and ionic disorders; 5) Rare hereditary diseases, such as sugar intolerance, glucose-galactose uptake disorder or sucrase-isomaltase deficiency; 6) History of dysphagia, esophageal stricture, esophageal varices, hiatal hernia, Z-E syndrome, or any other GI disease that affects drug absorption and gastric acid secretion; 7) History of Helicobacter pylori infection or GERD; 8) With disease that increases the risk of bleeding, such as acute gastritis or gastric and duodenal ulcers; 9) Smoking more than 5 cigarettes per day within 3 months before screening; 10) Positive in alcohol breath test, or alcohol abuse history (14 units per week: 1 unit = beer 285mL, or liquor 25mL, or wine 100mL); 11) Positive in urinary drug test, or drug abuse history in the past 3 years; 12) From the screening to three months after the last dose, subjects (including partners) have fertility plan, or can not take effective contraception, or have plans for sperm donation and egg donation; 13) Female subjects are breast-feeding, or the serum level of ß-HCG over the upper limit of normal range; 14) Blood donation or massive blood loss (>450 mL) within 3 months before screening; 15) Within 28 days before the study, take any drugs alters the activity of liver enzymes, or any inhibitor or inducers of CYP3A4, CYP2C19, P-gp or Bcrp, such as itraconazole, ketoconazole, or dinidalone; 16) Within 14 days before the study, take any prescription, OTC, vitamin or herbal products (especially PPIs, H2 antagonists, antacids, and drugs affecting gastrointestinal motility); 17) Within 14 days before the study, have excessive special food (including pitaya, mango, grapefruit) or vigorous exercise, or other factors affecting drug ADME; 18) Within 48 hours before pH monitoring on day -1, have chocolate, coffee, or other alcoholic or caffeine-containing food or drink; 19) Intolerant of high-fat meals or lactose (diarrhea after milk drinking); or on a sodium-limited diet; 20) Special diet or food requirements; 21) Intolerant of gastric pH monitoring; While locating pH monitoring tube on day -1, pH=2.5 at 10 cm below the upper edge of esophageal sphincter; 22) Participated in clinical trials within 3 months before screening; 23) Can not finish the study in accordance to the protocol; 24) Acute disease or concomitant drug usage before pH monitoring on day -1; 25) Other factors unsuitable for the study, per investigators' judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCinf;decrease of gastric integrated acidity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;gastric pH value; | — |
Countries
China
Contacts
Public ContactLin Yang; Jing Shan
Beijing Anzhen Hospital
Outcome results
None listed