Essential hypertension
Conditions
Interventions
KC group:Period 1:? H062 tablet administered under fasting conditions
?Period 2:? H062 tablet taken following consumption of a high-fat, high-calorie breakfast
CK group:Period 1:?H062 tablet taken following consumption of a high-fat, high-calorie breakfast
?Period 2:? H062 tablet administered under fasting conditions
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Participants who are able to understand and willing to comply with the clinical trial protocol to complete this study and voluntarily sign the informed consent form; (2) Gender: Male or female participants (both genders included); (3) Age: >=18 years; (4) Body weight: body weight >=50.0kg for men and >=45.0kg for women. Body mass index (BMI) = weight (kg)/height 2 (m^2), BMI in the range of 19.0-26.0 kg/m^2 (including critical value); (5) Diastolic blood pressure >=70mmHg and =100mmHg and < 140mmHg in the sitting position at rest during the screening period.
Exclusion criteria
Exclusion criteria: (1) Participants with a history of drug-induced or other causes of angioedema12; (2) Participants with serum potassium >5.5 mmol/L during screening or those with risk factors potentially elevating potassium levels (e.g., high-potassium diet)2; (3) Estimated glomerular filtration rate (eGFR) 8 cups/day, 1 cup=250 mL) within 3 months before or during screening7; (10) Regular alcohol consumption (>14 units/week; 1 unit=360 mL beer, 45 mL 40% spirits, or 150 mL wine) within 3 months before or during screening, inability to abstain during the trial, or alcohol breath test >0 mg/100 mL8; (11) Smoking >=5 cigarettes/day within 3 months before screening or inability to discontinue tobacco products during the trial8; (12) Excessive consumption of grapefruit (pomelo), pomelo, starfruit, mango, or pitaya beverages/foods within 14 days before screening, or intake within 48 hours prior to first dosing7; (13) Special dietary requirements, inability to comply with standardized diets, or dysphagia4; (14) Lactose intolerance (history of diarrhea after consuming milk)4; (15) Use of prescription drugs, over-the-counter medications, herbal medicines, or supplements within 14 days before first dosing7; (16) Use of hepatic enzyme inducers (e.g., barbiturates, carbamazepine, phenytoin, glucocorticoids) or inhibitors (e.g., SSRIs, cimetidine, diltiazem, omeprazole, macrolides, nitroimidazoles, hypnotics, verapamil, fluoroquinolones, antihistamines) within 30 days before or during screening27; (17) Use of oral contraceptives within 30 days before first dosing or long-acting estrogen/progestin injections/implantable rods within 6 months before first dosing4; (18) Vaccination within 28 days before or during screening4; (19) Participation in other clinical trials involving investigational products/devices within 3 months before or during screening, planning to join other trials during this study, or non-personal participation4; (20) Pregnancy/lactation, clinically significant abnormal blood pregnancy results, unprotected intercourse within 2 weeks before screening (females of childbearing potential), or participants (or partners) planning pregnancy, sperm/egg donation, or unwilling to use >=1 non-pharmacological contraception during and for 3 months post-trial4; (21) History of needle or b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Characteristics of Single Oral Administration of H062 Tablets (400mg/5mg) in Healthy Participants Under Fasting and High-Fat Meal Conditions?; | — |
Countries
China
Contacts
Public ContactZhang Wei
Henan Provincial People's Hospital
Outcome results
None listed