Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets (NCT06610890) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetic Interactions Between Hemay005 Tablets and Midazolam Maleate Tablets
China20 participantsStarted 2024-12-12
Plain-language summary
1. To evaluate the pharmacokinetics of Hemay005 tablets on midazolam and its active metabolite α-hydroxymidazolam after multiple administration;
2. Evaluate the effect of Hemay005 tablet on QT interval;
3. To investigate the effect of Hemay 005 tablets on inflammatory factors.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female subjects aged from 18 to 65 years old (including 18 and 65 years old), the ratio of male to female was 1:1;
* Body weight: male ≥50.0kg, female ≥45.0kg, body mass index \[BMI= weight (kg)/height 2 (m2)\] between 19.0 kg/m2 and 26.0kg/m2 (including boundary values);
* 90mmHg≤ systolic blood pressure \<140mmHg, 60mmHg≤ diastolic blood pressure \<90 mmHg, 60 beats/min ≤ pulse ≤100 beats/min, normal body temperature (abnormal vital signs could be retested, normal retest results were considered to meet the inclusion criteria);
* The results of ECG were normal or abnormal but not clinically significant, including QTcF≤450 ms in men and QTcF≤470 ms in women, PR interval
* 200ms and QRS complex duration ≤110 ms;
* Before the trial, they have understood the nature, significance, possible benefits, possible inconvenience and potential risks of the trial in detail, and voluntarily participate in the clinical trial, can communicate well with the investigators, comply with the requirements of the whole study, and sign the written informed consent.
Exclusion Criteria:
* those who participated in other drug clinical trials within 3 months;
* patients with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolic system, skeletal system and other systems…