Healthy volunteers
Conditions
Interventions
A:amitriptyline 25mg/qn,p.o. for 7 days
B:placebo 25mg/qn,p.o. for 7 days
Sponsors
Guangzhou First Municipal People's Hospital, Guangzhou Nansha Central Hospital Affiliated to Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female Chinese healthy volunteers; 2. Aged 18 to 65 years old; 3. Body mass index between 19-24kg/?; 4. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, chest x-ray examination, and 12-lead electrocardiogram (ECG); 5. Without depression and anxiety disease assessed by Zung self-assessment Depression Scale(ZSDS)and Zung self-assessment Anxiety Scale(ZSAS); 6. without cough, expectoration, sore throat, tonsil infection or acute upper respiratory tract infection for 3 months before entering the group; 7. Without the globus symptoms as well as esophageal reflux, heartburn, bloating or other gastrointestinal symptoms; 8. At least one week before the study, no use of drugs that can affect esophageal motility, such as Prokinetic drugs, sedatives, stimulants, antidepressants, anticholinergic drugs; 9. Signed informed consent, agreed to complete all the procedures as well as the esophageal motility manometry after detailed explanation.
Exclusion criteria
Exclusion criteria: 1. History of gastrointestinal surgery; 2. History of serious cardiovascular disease, pulmonary disease, renal diease, hepatical diease and gut disease; 3. Pregnancy or breast feeding; 4. Use of medications that may affect gastrointestinal motor function and the effect of amitriptyline; 5. History of gut disease or other disease that may affect gut motility; 6. Contraindications to amitriptyline, include hypersensitivity or allergy to any tricyclic drug, concomitant therapy with a monoamine oxidase inhibitor, recent myocardial infarction, myelography within previous 48 hours, history of urinary retention, known glaucoma, history of seizures, or thyroid or liver dysfunction are exclusionary criteria to the use of amitriptyline and to entry into this study; 7. Have participated in other clinical trial during last two weeks; 8. unable to withstand the esophageal manometry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UES resting pressure;UES residual pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| gastrointestinal hormone; | — |
Countries
China
Contacts
Public ContactLin Jia
Outcome results
None listed