Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is an open-label, fixed-sequence, self-controlled Phase I clinical trial conducted among obese or overweight subjects, with a planned enrollment of 40 adult subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Medication Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7535 Tablets | Drug | HRS-7535 tablet. |
| |
| Paracetamol Tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | 63 days. | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) | 63 days. | |
| Area under the concentration-time curve from time zero to infinity (AUC0-inf) | 63 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum concentration (Tmax) | Pharmacokinetic parameters of HRS-7535. | 63 days. |
| Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suzhou Municipal Hospital | Suzhou | Jiangsu | 215000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Paracetamol tablet. |
|
| Digoxin Tablets | Drug | Digoxin tablet. |
|
| Rosuvastatin Calcium Tablets | Drug | Rosuvastatin Calcium tablet. |
|
| Omeprazole Enteric-coated Capsules | Drug | Omeprazole Enteric-coated capsule. |
|
Pharmacokinetic parameters of HRS-7535.
| 63 days. |
| Elimination half-life (t1/2) | Pharmacokinetic parameters of HRS-7535. | 63 days. |
| Apparent clearance (CL/F) | Pharmacokinetic parameters of HRS-7535. | 63 days. |
| Apparent volume of distribution (Vz/F) | Pharmacokinetic parameters of HRS-7535. | 63 days. |
| Apparent volume of distribution (Vz/F) | Pharmacokinetic parameters of Paracetamol, Digoxin, Rosuvastatin and Omeprazole. | 63 days. |
| Apparent clearance (CL/F) | Pharmacokinetic parameters of Paracetamol, Digoxin, Rosuvastatin and Omeprazole. | 63 days. |
| Elimination half-life (t1/2) | Pharmacokinetic parameters of Paracetamol, Digoxin, Rosuvastatin and Omeprazole. | 63 days. |
| Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau) | Pharmacokinetic parameters of Paracetamol, Digoxin, Rosuvastatin and Omeprazole. | 63 days. |
| Time of maximum concentration (Tmax) | Pharmacokinetic parameters of Paracetamol, Digoxin, Rosuvastatin and Omeprazole. | 63 days. |
| Incidence of adverse events (AEs) | Safety measures. | 70 days. |
| Incidence of serious adverse events (SAEs) | Safety measures. | 70 days. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D004077 | Digoxin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013449 | Sulfonamides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided