Chronic Heart FailurePhase 1NCT06922253
Bioequivalence Study to Compare Sacubitril and Valsartan Tablets (97mg/103mg) Versus Entresto® (Sacubitril and Valsartan) Tablets (97 mg/103 mg)
A Phase 1 study testing Sacubitril and Valsartan-Test product and Sacubitril and Valsartan-Reference product in people with Chronic Heart Failure, run by Humanis Saglık Anonim Sirketi at 1 site in India.
Trial summary
An open label, balanced, randomized, single dose, two treatment, two sequence, four period, full-replicate, oral bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of HUMANİS SAĞLIK ANONİM ŞİRKETİ Ç.O.S.B., Karaağaç Mahallesi Fatih, Bulvarı No:32, Kapaklı/TEKİRDAĞ and Entresto® (Sacubitril and… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Sacubitril and Valsartan-Test product and Sacubitril and Valsartan-Reference product
- 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 siteIndia
- Study dates
- 28 Dec 2024to 17 Mar 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects aged between 18 and 45 years (both inclusive).
- Subjects' weight within normal range according to normal values for Body Mass Index (between 18.50 and 30.00 kg/m2) (both inclusive) with minimum of 45 kg weight.
- Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable range.
- Subject with Creatinine Clearance ≥80 ml/min.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- Subjects having clinically acceptable chest X-Ray (PA view), if taken.
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- Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- Subjects having negative urine alcohol test / breath alcohol test.
- Non-smokers.
- Subjects willing to adhere to the protocol requirements and to provide written informed consent.
- For male Subjects:
- Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as (a double barrier method) condom with spermicide, Condom with diaphragm, or abstinence. Subjects willing to refrain from donating sperm during the study period
- For Female Subjects: Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as intrauterine device (IUD), abstinence, bilateral tubal ligation or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above
- Subjects having negative urine pregnancy test at screening and negative serum β-hCG pregnancy test on admission day of period 01 (only for female subjects).
- Female Subjects who are non-pregnant and non-lactating.
Who cannot join
- Subjects having hypersensitivity to Sacubitril and Valsartan or related class of drugs or any of its excipients or heparin.
- Subject with the serum potassium level >5.4 mmol/l during screening.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
- Subjects who undergone any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission in period 01.
- History or presence of alcoholism or drug abuse.
- History or presence of asthma, urticaria or other significant allergic reactions.
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- History or presence of significant gastric and/or duodenal ulceration.
- History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- History or presence of cancer or basal or squamous cell carcinoma.
- Subject having difficulty with donating blood.
- Subjects having difficulty in swallowing solid dosage form like tablets or capsules.
- Use of any prescribed medication or OTC medication including vaccines, vitamins and herbal remedies during last 30 days prior to admission in period 01.
- Subject having major illness within past 03 months.
- Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
- Consumption of xanthine-containing products, tobacco containing products or alcohol or any alcohol containing products within 48.00 hours prior to admission in period 01.
- Consumption of grapefruit or grapefruit juice containing products within 72.00 hours prior to admission of period 01.
- Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
- History or presence of significant easy bruising or bleeding.
- History or presence of significant recent trauma.
- Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- Female subjects who are currently breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Four Period, Full-replicate, Oral Bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of Ç.O.S.B., Karaağaç Mahallesi Fatih, Bulvarı No:32, Kapaklı/TEKİRDAĞ and Entresto® (Sacubitril and Valsartan) 97 mg/103 mg Tablets of Novartis Europharm Limited, Irija in Healthy, Adult, Human Subjects Under Fasting Condition.
An open label, balanced, randomized, single dose, two treatment, two sequence, four period, full-replicate, oral bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of HUMANİS SAĞLIK ANONİM ŞİRKETİ Ç.O.S.B., Karaağaç Mahallesi Fatih, Bulvarı No:32, Kapaklı/TEKİRDAĞ and Entresto® (Sacubitril and Valsartan) 97 mg/103 mg Tablets of Novartis Europharm Limited, Irija in healthy, adult, human subjects under fasting condition.
- Conditions
- Chronic Heart Failure
- Being tested
- Sacubitril and Valsartan-Test product, Sacubitril and Valsartan-Reference product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril and Valsartan-Test productDrug
1 tablet of 97 mg Sacubitril / 103 mg Valsartan
Sacubitril and Valsartan-Reference productDrug
1 tablet of 97 mg Sacubitril / 103 mg Valsartan
| Study group | Role | What they receive |
|---|---|---|
| Sacubitril and Valsartan Tablets | Experimental | Sacubitril and Valsartan 97 mg / 103 mg Tablets Receives: Drug: Sacubitril and Valsartan-Test product |
| Entresto® (Sacubitril and Valsartan) Tablets | Experimental | Entresto® (Sacubitril and Valsartan) 97 mg / 103 mg Tablets Receives: Drug: Sacubitril and Valsartan-Reference product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
If the intra-subject CV of the reference formulation for Cmax is less than or equal to 30%, the conventional acceptance range of 80.00% - 125.00% for bioequivalence will be applied to Cmax.
Measured: 48.00 hours
Area Under the Curve from time zero to time of last measurable concentration (AUC0-t)
For, AUC0-t, acceptance range for bioequivalence is 80.00 - 125.00% for 90% confidence intervals of the geometric least square means ratio (T/R).
Measured: 48.00 hours
Secondary outcomes (4)
Area Under the Curve from time zero to time infinite (AUC0-∞)
descriptive statistics
Measured: 48.00 hours
Time to reach peak plasma concentration (Tmax)
descriptive statistics
Measured: 48.00 hours
Plasma Elimination Half-Life (t1/2)
descriptive statistics
Measured: 48.00 hours
The elimination rate constant (Kel)
descriptive statistics
Measured: 48.00 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start28 Dec 2024
- Primary completion20 Jan 2025
- Study completion17 Mar 2025
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922253
- Sponsor's protocol ID
- 24-VIN-0563
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 10 Apr 2025
- 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 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Single Dose, Two Treatment, Two Sequence, Four Period, Full-replicate, Oral Bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of Ç.O.S.B., Karaağaç Mahallesi Fatih, Bulvarı No:32, Kapaklı/TEKİRDAĞ and Entresto® (Sacubitril and Valsartan) 97 mg/103 mg Tablets of Novartis Europharm Limited, Irija in Healthy, Adult, Human Subjects Under Fasting Condition.
- ClinicalTrials.gov ID
- NCT06922253
- Acronym / sponsor ID
- 24-VIN-0563
- Conditions
- Chronic Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 10 Apr 2025 (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.
An open label, balanced, randomized, single dose, two treatment, two sequence, four period, full-replicate, oral bioequivalence Study of Sacubitril and Valsartan 97 mg/103 mg Tablets of HUMANİS SAĞLIK ANONİM ŞİRKETİ Ç.O.S.B., Karaağaç Mahallesi Fatih, Bulvarı No:32, Kapaklı/TEKİRDAĞ and Entresto® (Sacubitril and Valsartan) 97 mg/103 mg Tablets of Novartis Europharm Limited, Irija in healthy, adult, human subjects under fasting condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacubitril and Valsartan Tablets | Experimental | Drug: Sacubitril and Valsartan-Test productSacubitril and Valsartan 97 mg / 103 mg Tablets |
| Entresto® (Sacubitril and Valsartan) Tablets | Experimental | Drug: Sacubitril and Valsartan-Reference productEntresto® (Sacubitril and Valsartan) 97 mg / 103 mg Tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Subjects aged between 18 and 45 years (both inclusive).
- Subjects' weight within normal range according to normal values for Body Mass Index (between 18.50 and 30.00 kg/m2) (both inclusive) with minimum of 45 kg weight.
- Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable range.
- Subject with Creatinine Clearance ≥80 ml/min.
- Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
Key exclusion criteria (21 listed)
- Subjects having hypersensitivity to Sacubitril and Valsartan or related class of drugs or any of its excipients or heparin.
- Subject with the serum potassium level >5.4 mmol/l during screening.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder.
- Subjects who undergone any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to admission in period 01.
- History or presence of alcoholism or drug abuse.
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-Test product1 tablet of 97 mg Sacubitril / 103 mg Valsartan | Drug | Sacubitril and Valsartan Tablets |
| Sacubitril and Valsartan-Reference product1 tablet of 97 mg Sacubitril / 103 mg Valsartan | Drug | Entresto® (Sacubitril and Valsartan) Tablets |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 48.00 hours
If the intra-subject CV of the reference formulation for Cmax is less than or equal to 30%, the conventional acceptance range of 80.00% - 125.00% for bioequivalence will be applied to Cmax.
Area Under the Curve from time zero to time of last measurable concentration (AUC0-t)
Time frame: 48.00 hours
For, AUC0-t, acceptance range for bioequivalence is 80.00 - 125.00% for 90% confidence intervals of the geometric least square means ratio (T/R).
4 secondary outcomes
Area Under the Curve from time zero to time infinite (AUC0-∞)
Time frame: 48.00 hours
Time to reach peak plasma concentration (Tmax)
Time frame: 48.00 hours
Plasma Elimination Half-Life (t1/2)
Time frame: 48.00 hours
The elimination rate constant (Kel)
Time frame: 48.00 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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-Test product and Sacubitril and Valsartan-Reference product in people with Chronic Heart Failure, run by Humanis Saglık Anonim Sirketi at 1 site in India.
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 21 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: finished, as of the sponsor's last update on 10 Apr 2025. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 48.00 hours). 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 10 Apr 2025.