functional constipation
Conditions
Interventions
Single group, single arm, single dose:Blood sample collection
Sponsors
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Chinese healthy adult male volunteers aged 18-45 years old; 2) Weight >= 50.0 kg, BMI: 19.0-26.0kg/m^2 (including critical value), BMI=weight (kg)/height 2 (m^2); 3) Based on screening and/or baseline medical history, vital signs, physical examination, electrocardiogram, and laboratory tests, the results show normal or abnormal without clinical significance as determined by the researcher; 4) The screening test shows that serum magnesium is within the normal reference range; 5) Participants voluntarily participate in the trial and sign an informed consent form before the start of the study.
Exclusion criteria
Exclusion criteria: 1) Known or suspected allergy to magnesium sulfate; 2) Male participants who do not agree to use medically recognized effective contraceptive measures throughout the entire trial period and within 3 months after the end of the trial; 3) Individuals with weak physical constitution who are prone to diarrhea; Individuals with severe constipation, acute or chronic active gastrointestinal diseases, or those who have undergone gastrointestinal surgery (excluding appendectomy and inguinal hernia); 4) Existence of acute and chronic diseases such as cardiovascular, renal, respiratory, blood and lymphatic, endocrine, immune, psychiatric, and neurological disorders; 5) Individuals who have participated in clinical trials of other drugs within the past 3 months prior to enrollment; 6) Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, vitamins, or health supplements before screening, and whose expected time before the first administration is less than 5 half lives of the drug or less than 14 days (whichever is longer); 7) Blood loss or donation of >= 300mL within 3 months prior to enrollment, or planned blood donation during the study period; 8) Patients who cannot tolerate venipuncture blood collection; 9) HIV Ab HCV-AbHBsAg Individuals with positive syphilis test results; 10) Upon inquiry, individuals who have smoked more than 5 cigarettes per day or an equivalent amount of tobacco within the past 3 months prior to screening; 11) After inquiry, it was found that individuals who consumed a large amount of alcohol within the past 3 months and consumed more than 28 units of alcohol per week (1 unit=285 ml of beer, 25 ml of liquor, or 1 glass of wine) were screened; Or those who test positive for alcohol breath test within 24 hours before receiving the test drug; 12) Individuals who have a history of drug use or abuse, or have tested positive for drug abuse screening in the past two years; 13) Researchers believe that due to various reasons, participants are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum magnesium concentration; | — |
Countries
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Contacts
Public ContactAndroid Ling
Director of Pharmacy Department
Outcome results
None listed