Used to relieve occasional insomnia, especially when accompanied by mild pain
Conditions
Interventions
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age and gender: Healthy male or female subjects aged 18~60 years old (including 18 years old, excluding 60 years old). 2. Body weight index: male weight >=50.0kg, female weight >=45.0kg, 19.0kg/m²<=BMI<=26.0kg/m². Body mass index is calculated as follows: BMI (body mass index) = weight/height² (kg/m²). 3. Fully understand the content of the trial, the trial drug, the trial process, etc., be able to communicate well with the investigator, be willing to comply with the study regulations, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Individuals who have participated in any clinical trial and received investigational drugs, vaccines, or devices within 90 days prior to the study screening. 2.Individuals with a history of severe allergies (such as angioedema and anaphylactic shock), those with an allergic constitution (e.g., experiencing allergies to pollen, drugs, food, or the environment, cumulatively affecting two or more of these categories), or those known to be allergic to diphenhydramine, ibuprofen, other ethanolamine derivatives, or other non-steroidal anti-inflammatory drugs. 3.Individuals with a significant medical history or current diagnosis of major diseases affecting the cardiovascular system (e.g., coronary heart disease, hypertension), respiratory system (e.g., bronchial asthma), hematologic system (e.g., hemophilia), immune system, reproductive system, urinary system, metabolic disorders (e.g., hyperthyroidism), liver, kidneys, or benign/malignant tumors, or those with psychiatric disorders or other conditions deemed unsuitable for participation in the clinical trial by the investigator. 4.Individuals with a history of myasthenia gravis. 5.Individuals with a history of angle-closure glaucoma. 6.Individuals with a history of benign prostatic hyperplasia (BPH) or bladder neck stenosis. 7.Individuals with a history of any gastrointestinal disease that may affect drug absorption (such as gastric or small bowel resection, atrophic gastritis, gastrointestinal ulcer, perforation, or fistula, gastrointestinal bleeding, obstruction, etc.), or those who have experienced gastrointestinal symptoms such as nausea or vomiting within 14 days prior to screening and are deemed unsuitable for participation by the investigator. 8.Individuals with a history of surgery that, in the investigator's judgment, may affect drug absorption, distribution, metabolism, or excretion (including all individuals who have undergone hepatic, renal, or gastrointestinal resection), or those who have undergone surgical procedures within 4 weeks prior to screening, or those planning to undergo surgery during the study period. 9.Individuals who have used any medication (including prescription drugs, over-the-counter drugs, herbal medicines, vitamins, or dietary supplements) for any reason within 14 days prior to study screening. 10.Individuals who have received any vaccination within 1 month prior to study screening, or those who plan to receive vaccinations during the course of the study. 11.Individuals who have used any medication within 30 days prior to study screening that may interact with diphenhydramine or ibuprofen (e.g., heparin, coumarin, digoxin, methotrexate, hypoglycemic agents, furosemide, antihypertensive agents, etc.). 12.Individuals who are unable to tolerate intravenous puncture or blood collection via indwelling cannula, or those with a history of blood phobia or needle phobia. 13.Individuals who have donated blood or experienced blood loss exceeding 400 mL within 90 days prior to study screening, or those who have received blood transfusions or used blood products, or those planning to donate blood or blood components during the study period. 14.Individuals with a history of drug abuse or drug dependence, or those who have used soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to the first administration, or those with a positive result in the urine multi-drug screening test upon first admission. 15.Individua
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed