CompletedPhase 1

Bioavailability and Food Effects of HRS-7535 Tablets With Different Formulating Processes in Healthy Subjects

China24 participantsStarted 2024-05-23

Plain-language summary

This study was designed as a a single-center, randomized, open, interleaved (3-cycle, 3-sequence) trial. It is planned to enroll 18 healthy subjects.

Who can participate

Age range18 Years – 45 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

✓. Able and willing to provide a written informed consent;
✓. Male or female aged 18-45 at screening (both inclusive);
✓. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI) : 18-30 kg/m2 (including both ends of the value);
✓. Subjects (including male subjects) are willing to have no birth plan and voluntarily adopt effective contraceptive measures and no sperm donation plan from Signed informed consent to the last two weeks after the administration of no fertility plan and no sperm donation, egg donation plan, and agree to take effective contraceptive measures.

Exclusion criteria

✕. Those who had a smoking history in the 3 months before screening (average daily smoking \> 5 cigarettes), or could not stop using any tobacco products during the test;
✕. Those who consumed an average of more than 25 g of alcohol per day (e.g., 750 mL beer, 250 mL wine, or 50 mL liquor) in the three months prior to screening, or who could not abstain during the trial period;
✕. Consumed any beverage or food containing grapefruit in the 7 days prior to screening; Or consumed any beverage or food containing methylxanthine within 2 days prior to screening, such as coffee, tea, cola, chocolate, etc.
✕. Allergy, or suspected allergy to any ingredient in HRS-7535 preparation;
✕. A history of drug abuse in the past five years or use of drugs in the three months prior to the test; Or a positive urine drug test;
✕. A history of any clinically serious disease or disease or condition that the investigator believes may affect the test results, including but not limited to circulatory, endocrine, nervous, digestive, urinary, or blood, immune, psychiatric, or metabolic disorders;
✕. Abnormalities with QTcF \> 450 ms detected by 12-lead electrocardiogram at screening or baseline and judged by investigators to be clinically significant;
✕. Vital signs, physical examination, laboratory examination, abdominal ultrasound or chest imaging examination at the time of screening or at baseline suggest abnormalities that the investigators have determined to be clinically significant;

What they're measuring

PK parameters：Cmax

Timeframe: 0 hour to 72 hours after the last dosing

PK parameters：AUC0-t

Timeframe: 0 hour to 72 hours after the last dosing

PK parameters：AUC0-∞

Timeframe: 0 hour to 72 hours after the last dosing

Relative bioavailability of HRS-7535 (D) tablets compared to HRS-7535 (C) tablets following a high-fat meal

Timeframe: 0 hour to 72 hours after the last dosing

Relative bioavailability of HRS-7535 (D) tablets under both fasting and fed (high fat meal) status

Timeframe: 0 hour to 72 hours after the last dosing

Trial details

NCT IDNCT06422039

SponsorShandong Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-06

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus trials

Who can participate

Age range18 Years – 45 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

✓. Able and willing to provide a written informed consent;
✓. Male or female aged 18-45 at screening (both inclusive);
✓. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI) : 18-30 kg/m2 (including both ends of the value);
✓. Subjects (including male subjects) are willing to have no birth plan and voluntarily adopt effective contraceptive measures and no sperm donation plan from Signed informed consent to the last two weeks after the administration of no fertility plan and no sperm donation, egg donation plan, and agree to take effective contraceptive measures.

Exclusion criteria

✕. Those who had a smoking history in the 3 months before screening (average daily smoking \> 5 cigarettes), or could not stop using any tobacco products during the test;
✕. Those who consumed an average of more than 25 g of alcohol per day (e.g., 750 mL beer, 250 mL wine, or 50 mL liquor) in the three months prior to screening, or who could not abstain during the trial period;
✕. Consumed any beverage or food containing grapefruit in the 7 days prior to screening; Or consumed any beverage or food containing methylxanthine within 2 days prior to screening, such as coffee, tea, cola, chocolate, etc.
✕. Allergy, or suspected allergy to any ingredient in HRS-7535 preparation;
✕. A history of drug abuse in the past five years or use of drugs in the three months prior to the test; Or a positive urine drug test;
✕. A history of any clinically serious disease or disease or condition that the investigator believes may affect the test results, including but not limited to circulatory, endocrine, nervous, digestive, urinary, or blood, immune, psychiatric, or metabolic disorders;
✕. Abnormalities with QTcF \> 450 ms detected by 12-lead electrocardiogram at screening or baseline and judged by investigators to be clinically significant;
✕. Vital signs, physical examination, laboratory examination, abdominal ultrasound or chest imaging examination at the time of screening or at baseline suggest abnormalities that the investigators have determined to be clinically significant;

What they're measuring

PK parameters：Cmax

Timeframe: 0 hour to 72 hours after the last dosing

PK parameters：AUC0-t

Timeframe: 0 hour to 72 hours after the last dosing

PK parameters：AUC0-∞

Timeframe: 0 hour to 72 hours after the last dosing

Relative bioavailability of HRS-7535 (D) tablets compared to HRS-7535 (C) tablets following a high-fat meal

Timeframe: 0 hour to 72 hours after the last dosing

Relative bioavailability of HRS-7535 (D) tablets under both fasting and fed (high fat meal) status

Timeframe: 0 hour to 72 hours after the last dosing