Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets
ConditionPrimary Hypertension
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShenzhen Salubris Pharmaceuticals Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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) / height² (m²). BMI must be within the range of 19 to 26 kg/m² (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
Disqualifiers
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 (multiple drug and food allergies).
Alcoholics or those who frequently consumed alcohol within the 3 months prior to screening, i.e., consuming more than 14 standard alcohol units per week (1 unit alcohol = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine), or those with a positive alcohol breath test, or those unable to stop using any alcohol-containing products during the trial period.
Trial design
Design model
Crossover
Treatments tested in this trial
Sequence A T-R-T-R
DrugThe medication sequence for sequence A is as follows: in the first and third cycles, the test formulation (T: Sacubitril Alesartan Amlodipine Tablets) is taken; in the second and fourth cycles, the reference formulation (R: Sacubitril Alesartan Calcium Tablets + Benazepril Amlodipine Tablets) is taken.The administration date should be at least 14 days apart each time.
Sequence B R-T-R-T
DrugThe administration sequence for sequence B is as follows: in the first and third cycles, the reference formulation (R: sacubitril amlasiatin calcium tablet + benazepril hydrochloride tablet) is administered; in the second and fourth cycles, the test formulation (T: sacubitril amlasiatin and hydrochloride tablet) is administered; each administration date is at least 14 days apart.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Sequence A T-R-T-RExperimental treatment 1 intervention
Group B: Sequence B R-T-R-TOther 1 intervention
Trial outcomes
Primary outcomes
1
Cmax of EXP3174、Sacubitril、LBQ657、Amlodipine
Time frame
through study completion，an average of 47days2
AUC0-t of EXP3174、Sacubitril、LBQ657
Time frame
through study completion，an average of 47days3
AUC0-∞of EXP3174、Sacubitril、LBQ657
Time frame
through study completion，an average of 47days4
AUC0-72h of Amlodipine
Time frame
From 0 o'clock to 72 hoursSponsors and contacts
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Source ClinicalTrials.gov
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