Healthy VolunteersPhase 1NCT06193187
A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
A Phase 1 study testing Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg and Entresto 50 mg in people with Healthy Volunteers, run by Dr. Reddy's Laboratories (Thailand) Limited at 1 site in Thailand.
Trial summary
To evaluate the bioequivalence between two formulations of sacubitril/valsartan 24 mg/26 mg film-coated tablets, Entresto 50 mg (Reference) and Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg (Test), after a single oral dose administration in healthy Thai subjects under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg and Entresto 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2024to Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Thai Male/Female must be 18-55 years of age, body weight >50.0 kg with body mass index (BMI) = 18.0-30.0 kg/m2, inclusive.
- Must be in good health as determined by medical history, vital signs (blood pressure (systolic blood pressure not lower than 100 or not over 139 mmHg, diastolic blood pressure not lower than 70 or not over 89 mmHg), body temperature, pulse rate, respiratory rate) and physical examination or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians
- Screening ECG without clinically significant abnormalities
- Screening visit laboratory values of blood test including hematology (CBC with differential), serum potassium, FBS, BUN, Cr, and liver function test (AST, ALT, total bilirubin and ALP) must be within the normal range or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians.
- Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians.
- Must have serum HBsAg, anti-HCV and anti-HIV negative
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- Female subject must have serum β-hCG negative or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians.
- Female subject of childbearing potential or male subject agrees to use an acceptable birth control method from visit 1 to the follow-up visit. The acceptable birth control method is defined as a barrier method of contraception (including condoms, intrauterine device and diaphragm with spermicidal agent) or total abstinence from sexual intercourse from visit 1 to the follow-up visit. Hormonal contraceptives are not acceptable.
- Female subject of non-childbearing potential (hysterectomy, both ovaries removed, surgically sterilized or postmenopausal (for at least 12 consecutive months of amenorrhea))
- Female subject must agree not to become pregnant for the entire participation period and must have a negative result for a urine pregnancy test performing prior to dosing at Period 1, Period 2, Period 3 and Period 4.
- Non-smoker (never smoked or no smoking within the previous 1 year)
- Refrain from using herbal medications, cannabis containing products, dietary supplements (e.g., St. John's Wort, ginkgo biloba, garlic supplements), vitamins, grapefruit or grapefruit juice, or pomelo within 14 days before the first administration of investigational product (Day 1). Subjects must agree to refrain from these items until the last collection time-point of Period 4.
- Subject must have ended any systemic medications or any medications that have any impact on gastrointestinal system at least 30 days prior to Day 1 or at least 5 times of elimination half-life prior to Day 1 and agree to continue their refraining throughout the follow-up period.
- Subject must refrain from drinking caffeine and alcohol for at least 72 hours prior to Day 1 and agree to continue their refraining throughout the last collection time-point of Period 4.
- Have the ability to understand the requirements of the study and must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures
Who cannot join
- Known hypersensitivity to sacubitril or valsartan or any other similar class of drugs or its components
- Past medical history of renal and hepatic insufficiency
- Subject has a history of any illness that, in the opinion of Principal/Clinical Investigator or designated physicians, might confound the result of the study or pose an additional risk in administering investigational product to the subject. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements.
- History of hereditary or idiopathic angioedema
- Have a history of angioedema related to previous ACE inhibitor or ARB therapy
- Have serum potassium level >5.4 mmol/L
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- Have history of drug abuse (in the opinion of Principal/Clinical Investigator or designated physicians, as judged by medical history) in the last 12 months
- Have positive result of urine drug abuse testing on opioids (Mor, MTD), cannabinoids (THC), Meth, Coc or MDMA at screening visit or before dose administration at each period
- Alcohol abuse or excessive use (in the opinion of Principal/Clinical Investigator or designated physicians, as judged by medical history) in the last 12 months
- Have positive result of alcohol breathing test at screening visit or before dose administration at each period
- Female subject is pregnant or breast feeding.
- Difficulties fasting or consuming standard meals
- Difficulties swallowing whole tablets
- Donation or loss of whole blood:
- ≥50 mL and ≤499 mL within 30 days prior to Day 1
- ≥500 mL within 56 days prior to Day 1
- Participation in any investigational drug study within 30 days from screening visit (from the last follow-up visit to the screening visit).
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Siriraj Institute of Clinical Research (SICRES)
Bangkok, 10700
Assoc. Prof. Somruedee Chatsiricharoenkul, M.D., +66 2419 7571, somruedee.cha@mahidol.ac.th
About this study
Official title: A Bioequivalence Study of Two Formulations of Sacubitril/Valsartan 24 mg/26 mg Film-coated Tablets in Healthy Thai Subjects Under Fasting Conditions
To evaluate the bioequivalence between two formulations of sacubitril/valsartan 24 mg/26 mg film-coated tablets, Entresto 50 mg (Reference) and Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg (Test), after a single oral dose administration in healthy Thai subjects under fasting conditions.
Read the detailed description
This study will be an open label, single dose, randomized, two-formulation, four-period, two-sequence, fully replicate crossover study. In this study, 48 healthy subjects will be randomized into two cohorts to receive a single dose of sacubitril and valsartan 24 mg/26 mg film-coated tablets for 48 hours and will be separated by a washout period of 7 days. This study will be conducted at one clinical site.
- Conditions
- Healthy Volunteers
- Being tested
- Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg, Entresto 50 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril and Valsartan Sodium Tablets 24 mg/26 mgDrug
Test (T)
Entresto 50 mgDrug
Reference (R)
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: TRTR | Experimental | According to the randomization table, subjects will be randomly assigned to the Sequence 1: Test (T)-Reference (R)-Test (T)-Reference (R) for Period 1,2,3 and 4, respectively. The washout period between doses will be at least 7 days. Receives: Drug: Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg; Drug: Entresto 50 mg |
| Sequence 2: RTRT | Experimental | According to the randomization table, subjects will be randomly assigned to the Sequence 2: Reference (R)-Test (T)-Reference (R)-Test (T) for Period 1,2,3 and 4, respectively. The washout period between doses will be at least 7 days. Receives: Drug: Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg; Drug: Entresto 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 48 hours
Area under the plasma concentration versus time curve (AUC0-t)
Area under the concentration-time profile to the last quantifiable concentration (AUC0-t)
Measured: 48 hours
Area under the plasma concentration versus time curve (AUC0-∞)
Area under the concentration-time profile following administration of a single dose, extrapolated to infinite time (AUC0-∞)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories (Thailand) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Assoc. Prof. Somruedee Chatsiricharoenkul, M.D., Mahidol University
- Investigators
- Assoc. Prof. Somruedee Chatsiricharoenkul, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193187
- Sponsor's protocol ID
- MI-23-sacubitril/valsartan-02
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study of Two Formulations of Sacubitril/Valsartan 24 mg/26 mg Film-coated Tablets in Healthy Thai Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06193187
- Acronym / sponsor ID
- MI-23-sacubitril/valsartan-02
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Dr. Reddy's Laboratories (Thailand) LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the bioequivalence between two formulations of sacubitril/valsartan 24 mg/26 mg film-coated tablets, Entresto 50 mg (Reference) and Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg (Test), after a single oral dose administration in healthy Thai subjects under fasting conditions.
Detailed description
This study will be an open label, single dose, randomized, two-formulation, four-period, two-sequence, fully replicate crossover study. In this study, 48 healthy subjects will be randomized into two cohorts to receive a single dose of sacubitril and valsartan 24 mg/26 mg film-coated tablets for 48 hours and will be separated by a washout period of 7 days. This study will be conducted at one clinical site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: TRTR | Experimental | Drug: Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg, Drug: Entresto 50 mgAccording to the randomization table, subjects will be randomly assigned to the Sequence 1: Test (T)-Reference (R)-Test (T)-Reference (R) for Period 1,2,3 and 4, respectively. The washout period between doses will be at least 7 days. |
| Sequence 2: RTRT | Experimental | Drug: Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg, Drug: Entresto 50 mgAccording to the randomization table, subjects will be randomly assigned to the Sequence 2: Reference (R)-Test (T)-Reference (R)-Test (T) for Period 1,2,3 and 4, respectively. The washout period between doses will be at least 7 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Thai Male/Female must be 18-55 years of age, body weight >50.0 kg with body mass index (BMI) = 18.0-30.0 kg/m2, inclusive.
- Must be in good health as determined by medical history, vital signs (blood pressure (systolic blood pressure not lower than 100 or not over 139 mmHg, diastolic blood pressure not lower than 70 or not over 89 mmHg), body temperature, pulse rate, respiratory rate) and physical examination or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians
- Screening ECG without clinically significant abnormalities
- Screening visit laboratory values of blood test including hematology (CBC with differential), serum potassium, FBS, BUN, Cr, and liver function test (AST, ALT, total bilirubin and ALP) must be within the normal range or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians.
- Urinalysis results within normal limit or showing no clinically significant abnormalities in the opinion of Principal/Clinical Investigator or designated physicians.
Key exclusion criteria (17 listed)
- Known hypersensitivity to sacubitril or valsartan or any other similar class of drugs or its components
- Past medical history of renal and hepatic insufficiency
- Subject has a history of any illness that, in the opinion of Principal/Clinical Investigator or designated physicians, might confound the result of the study or pose an additional risk in administering investigational product to the subject. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements.
- History of hereditary or idiopathic angioedema
- Have a history of angioedema related to previous ACE inhibitor or ARB therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacubitril and Valsartan Sodium Tablets 24 mg/26 mgTest (T) | Drug | Sequence 1: TRTR, Sequence 2: RTRT |
| Entresto 50 mgReference (R) | Drug | Sequence 1: TRTR, Sequence 2: RTRT |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 48 hours
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC0-t)
Time frame: 48 hours
Area under the concentration-time profile to the last quantifiable concentration (AUC0-t)
Area under the plasma concentration versus time curve (AUC0-∞)
Time frame: 48 hours
Area under the concentration-time profile following administration of a single dose, extrapolated to infinite time (AUC0-∞)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assoc. Prof. Somruedee Chatsiricharoenkul, M.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sacubitril and Valsartan Sodium Tablets 24 mg/26 mg and Entresto 50 mg in people with Healthy Volunteers, run by Dr. Reddy's Laboratories (Thailand) Limited at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Assoc. Prof. Somruedee Chatsiricharoenkul, M.D. (+66 2419 7571, somruedee.cha@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.