Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets (NCT07486453) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets
China60 participantsStarted 2026-03-09
Plain-language summary
This study aims to evaluate the bioequivalence and safety of single oral administration of Sacubitril/Valsartan/Amlodipine Tablets (240mg/5mg) versus Sacubitril/Valsartan Calcium Tablets (240mg) combined with Amlodipine Besylate Tablets (5mg) in healthy adult study participants.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Study participants aged 18 to 60 years (inclusive of 18 and 60 years), both male and female
* Body weight not less than 50 kg. Body Mass Index (BMI) = weight (kg) / height\^2 (m\^2). BMI must be within the range of 19 to 26 kg/m\^2 (inclusive of the limit values)
* The study participant is able to communicate well with the research staff, fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial, and sign a written informed consent form
* The study participant or their partner has no plans for pregnancy, sperm donation, or egg donation during the study period and for 3 months after drug administration, and must agree to use at least one acceptable effective contraceptive method
* During the screening period: 110 mmHg ≤ seated systolic blood pressure (SBP) \< 140 mmHg, 65 mmHg ≤ seated diastolic blood pressure (DBP) \< 90 mmHg, and no orthostatic hypotension.
Exclusion Criteria:
* Those who smoked more than 5 cigarettes per day on average in the 3 months prior to the trial and are unable to quit smoking during the trial period.
* Pregnant or breastfeeding women, or female study participants of childbearing potential with a positive blood pregnancy screening.
* Known allergic reaction to angiotensin II receptor antagonists (such as sacubitril/valsartan sodium, alisartan ester, losartan, valsartan) and calcium channel blockers (such as nifedipine, amlodipine), or their excipients; or allergic constitution …
What they're measuring
1
Cmax of EXP3174、Sacubitril、LBQ657、Amlodipine
Timeframe: through study completion,an average of 47days
2
AUC0-t of EXP3174、Sacubitril、LBQ657
Timeframe: through study completion,an average of 47days
3
AUC0-∞of EXP3174、Sacubitril、LBQ657
Timeframe: through study completion,an average of 47days