Chronic Heart FailurePhase 1NCT06266988
A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
A Phase 1 study testing Sacubitril and Valsartan Tablets 97mg/103mg and Entresto (Sacubitril and Valsartan Tablets 97mg/103mg) in people with Chronic Heart Failure, run by Viatris Inc..
Trial summary
Primary objective is to is to evaluate the bioequivalence of two formulations Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Sacubitril and Valsartan Tablets 97mg/103mg and Entresto (Sacubitril and Valsartan Tablets 97mg/103mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Mar 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), FBS (Fasting Blood sugar), BUN (Blood urea Nitrogen), Cr, and liver function test (AST (Aspartate transaminase), ALT (Alanine transaminase) , total bilirubin and ALP (Alkaline phosphatase)) 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.
- Subject willing to avoid or follow precautions while driving, operating machinery and while working on high elevations.
- Female subject of childbearing potential or male subject agrees to use an acceptable birth control method from screening visit to the followup 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)
- Subject willing to not participate in blood donations (≥500 mL) until 56 days after completion of the study (last subject visit) and willing to not participate in clinical research studies until 30 days after completion of the study (last subject visit).
- 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 48 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 history of drug abuse (in the opinion of Principal/Clinical Investigator or designated physicians, as judged by medical history) in the last 12 months
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- 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
No sites are listed yet.
About this study
Official title: A Bioequivalence Study of Two Formulations of Sacubitril/Valsartan 97 mg/103 mg Film-coated Tablets in Healthy Thai Subjects Under Fasting Conditions
Primary objective is to is to evaluate the bioequivalence of two formulations
Read the detailed description
The objectives of this study is to evaluate the bioequivalence of two formulations of sacubitril/valsartan 97 mg/103 mg film coated tablets, Entresto® (Reference) and Sacubitril and Valsartan Tablets 97mg/103mg (Test), after a single oral dose administration in healthy Thai subjects under fasting conditions and secondarily to examine the pharmacokinetics and safety of sacubitril, sacubitrilat and valsartan in healthy Thai subjects under fasting conditions
- Conditions
- Chronic Heart Failure
- Being tested
- Sacubitril and Valsartan Tablets 97mg/103mg, Entresto (Sacubitril and Valsartan Tablets 97mg/103mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril and Valsartan Tablets 97mg/103mgDrug
Also called Sacubitril and Valsartan Tablets
Each Tablet contains 97 mg of Sacubitril and 103 mg of Valsartan
Entresto (Sacubitril and Valsartan Tablets 97mg/103mg)Drug
Also called Entresto
Each Tablet contains 97.2 mg sacubitril and 102.8 mg valsartan as sodium salt complex
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Sacubitril and Valsartan Tablets 97mg/103mg to be orally administered Receives: Drug: Sacubitril and Valsartan Tablets 97mg/103mg |
| Reference product | Active comparator | Entresto® (97.2 mg sacubitril and 102.8 mg valsartan as sodium salt complex) to be orally administered Receives: Drug: Entresto (Sacubitril and Valsartan Tablets 97mg/103mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax period (using the validated Phoenix® WinNonlin® software)
According to bioequivalence criteria, the 90% CI of the geometric mean ratio of Cmax should lie within 80.00-125.00%.
Measured: Upto 48 hours post-dose in each treatment
Bioequivalence based on AUC period (using the validated Phoenix® WinNonlin® software)
According to bioequivalence criteria, the 90% CI of the geometric mean ratio of AUC should lie within 80.00-125.00%.
Measured: Upto 48 hours post-dose in each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionApr 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 Chronic Heart FailureStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ariya Khunvichai, Ph.D, Study director, Medica Innova Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266988
- Sponsor's protocol ID
- SCVL-TFZ-1010
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 20 Feb 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 20 Feb 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 97 mg/103 mg Film-coated Tablets in Healthy Thai Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT06266988
- Acronym / sponsor ID
- SCVL-TFZ-1010
- Conditions
- Chronic Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2024 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 20 Feb 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.
Primary objective is to is to evaluate the bioequivalence of two formulations
Detailed description
The objectives of this study is to evaluate the bioequivalence of two formulations of sacubitril/valsartan 97 mg/103 mg film coated tablets, Entresto® (Reference) and Sacubitril and Valsartan Tablets 97mg/103mg (Test), after a single oral dose administration in healthy Thai subjects under fasting conditions and secondarily to examine the pharmacokinetics and safety of sacubitril, sacubitrilat and valsartan in healthy Thai subjects under fasting conditions
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Drug: Sacubitril and Valsartan Tablets 97mg/103mgSacubitril and Valsartan Tablets 97mg/103mg to be orally administered |
| Reference product | Active comparator | Drug: Entresto (Sacubitril and Valsartan Tablets 97mg/103mg)Entresto® (97.2 mg sacubitril and 102.8 mg valsartan as sodium salt complex) to be orally administered |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 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), FBS (Fasting Blood sugar), BUN (Blood urea Nitrogen), Cr, and liver function test (AST (Aspartate transaminase), ALT (Alanine transaminase) , total bilirubin and ALP (Alkaline phosphatase)) 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 (16 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 Tablets 97mg/103mgAlso: Sacubitril and Valsartan TabletsEach Tablet contains 97 mg of Sacubitril and 103 mg of Valsartan | Drug | Test Product |
| Entresto (Sacubitril and Valsartan Tablets 97mg/103mg)Also: EntrestoEach Tablet contains 97.2 mg sacubitril and 102.8 mg valsartan as sodium salt complex | Drug | Reference product |
Primary outcome
Bioequivalence based on Cmax period (using the validated Phoenix® WinNonlin® software)
Time frame: Upto 48 hours post-dose in each treatment
According to bioequivalence criteria, the 90% CI of the geometric mean ratio of Cmax should lie within 80.00-125.00%.
Bioequivalence based on AUC period (using the validated Phoenix® WinNonlin® software)
Time frame: Upto 48 hours post-dose in each treatment
According to bioequivalence criteria, the 90% CI of the geometric mean ratio of AUC should lie within 80.00-125.00%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 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.
Ariya Khunvichai, Ph.D study director
Medica Innova Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sacubitril and Valsartan Tablets 97mg/103mg and Entresto (Sacubitril and Valsartan Tablets 97mg/103mg) in people with Chronic Heart Failure, run by Viatris Inc..
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 17 inclusion and 16 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Arun Kumar, M.Pharm (967630054, akumar@viatris.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence based on Cmax period (using the validated Phoenix® WinNonlin® software) (time frame: Upto 48 hours post-dose in each treatment). The study lists 2 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 20 Feb 2024.