Healthy ParticipantsPhase 1(BABE)NCT07746908
Bioequivalence Study of Valsatril Tablet Versus Entresto® Sacubitril/Valsartan 24/26 mg Tablet.
A Phase 1 study testing Valsatril® and Entresto® in people with Healthy Participants, run by Center for Bioequivalence Studies and Clinical Research at 1 site in Pakistan.
Trial summary
This study is to evaluate the bioequivalence of Valsatril (Sacubitril/Valsartan) tablet 50 mg versus Entresto 50 mg tablet in healthy Pakistani volunteers under Fasting condition. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Valsatril® and Entresto®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Feb 2025to 18 Jul 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged 18 to 55 years inclusive.
- Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive).
- Subjects who are healthy as determined by routine physical examination, including vital sign monitoring and laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis).
- Subjects should have negative urine test for drugs of abuse and alcohol breath analysis at screening and prior to each check-in.
- All subjects should be free from any epidemic or contagious diseases (e.g., Malaria, Dengue, Covid-19)
- Subjects agreed to sign the Informed Consent Form
- Subjects agreed not to consume grapefruit and/or its products within 14 days prior to the start of study.
- Subjects agreed to discontinue Vitamin, dietary supplements and herbal products 14 days prior to the first dose of study medication.
Who cannot join
- Inability to take oral medication
- History of smoking (≤3 cigarette/day), alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological /connective tissue, musculoskeletal, metabolic/nutritional, endocrine, allergy, or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication..
- Known hypersensitivity to any xenobiotic and Sacubitril/Valsartan or any of the excipients.
- A prior history of angioedema due to an ACEI or ARB.
- Subject received any of the investigational drug within four weeks.
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- Subjects with salt imbalance in the blood (especially high levels of potassium in the blood).
- Donation or loss of more than 400 mL of blood within 3 months prior to the screening.
- Ingestion of OTC drug, within 07 days of drug administration.
- History of intake of any prescribed medicine during a period of 14 days, prior to drug administration
- Subjects who test positive for syphilis (VDRL) or who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBs Ag) or are carriers of antibodies to hepatitis C virus (anti-HCV) or to the human immunodeficiency virus (HIV-1 or HIV-2).
- Subject with history of any illness that, in the opinion of investigator might confound the result of the study or post additional risk in administrating Sacubitril /Valsartan to the subjects.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Center for Bioequivalence Studies and Clinical Research (CBSCR) , ICCBS, University of Karachi
Karachi, Sindh, 75270
About this study
Official title: An Open Label, Two Treatments, Single Dose, Cross Over, Bioequivalence Study of Valsatril Tablet of SAMI Pharmaceuticals Pvt. Ltd. Versus Entresto® Tablet of Novartis Pharmaceuticals Ltd., Under Fasting Condition in Adult Healthy Subjects.
This study is to evaluate the bioequivalence of Valsatril (Sacubitril/Valsartan) tablet 50 mg versus Entresto 50 mg tablet in healthy Pakistani volunteers under Fasting condition.
Read the detailed description
This will be a randomized, open-label, single-center, single-dose, two-treatment, two-period, two sequence crossover bioequivalence study in healthy adult participants with at least a 7-day washout period between treatment administrations.
A sufficient number of participants were screened to randomize approximately 60 participants, Participants were randomly assigned to one of the two treatment sequences and receive a single dose of each treatments in each (of 2) periods following a crossover design.
Blood was sampled regularly at scheduled times for 48 hours following treatment in each period to assess the pharmacokinetic parameters.
- Conditions
- Healthy Participants
- Being tested
- Valsatril®, Entresto®
- Keywords
- Bioequivalence, Sacubitril, Valsartan, Pakistan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsatril®Drug
Also called Angiotensin Receptor-Neprilysin Inhibitor (ARNI)
(Sacubitril/Valsartan) 24 mg/26 mg tablet of SAMI Pharmaceuticals (Pvt) Ltd
Entresto®Drug
Also called Angiotensin Receptor-Neprilysin Inhibitor (ARNI)
Entresto® (Sacubitril/Valsartan) 24 mg/26 mg tablet of Novartis Pharmaceuticals Ltd
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Oral administration of Valsatril (Sacubitril/Valsartan) 24/26 mg Tablet with 240 mL of ambient temperature water after at least 10 hours fast at their specified dosing time-points. Receives: Drug: Valsatril® |
| Reference Group | Active comparator | Oral administration of Entresto (Sacubitril/Valsartan) 24/26 mg Tablet with 240 mL of ambient temperature water after at least 10 hours fast at their specified dosing time-points. Receives: Drug: Entresto® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under the plasma drug concentration time curve
Measured: 0-48 hours post dose
Cmax
Maximum Plasma Concentration
Measured: 0 - 48 hours post dose
Secondary outcomes (5)
Tmax,
Time required for maximum plasma drug concentration,
Measured: 0-48 hours post dose
t1/2
Half Life.
Measured: 0-48 hours post dose
Blood Pressure
monitoring of blood pressure both systolic pressure and diastolic pressure, after dose administration
Measured: 0-48 hours post dose
Body temperature
post dose body temperature measurement
Measured: 0-48 hours post dose
Heart rate.
Measurement of heart rate after dosing..
Measured: 0-48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start6 Feb 2025
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Model description
- Open label, randomized, single-dose, two way cross-over study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Bioequivalence Studies and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- SAMI Pharmaceuticals (Pvt.) Ltd.
- Responsible party
- Principal investigator, Dr. Naghma Hashmi, Center for Bioequivalence Studies and Clinical Research
- Investigators
- Dr. M. Raza Shah, Principal investigator, Center for Bioequivalence Studies and Clinical ResearchDr. Naghma Hashmi, Principal investigator, Center for Bioequivalence Studies and Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746908
- Sponsor's protocol ID
- CB(BABE)-048-SAV(V)-2023
- Acronym
- (BABE)
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2026
- Last updated
- 10 Aug 2026
- 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Two Treatments, Single Dose, Cross Over, Bioequivalence Study of Valsatril Tablet of SAMI Pharmaceuticals Pvt. Ltd. Versus Entresto® Tablet of Novartis Pharmaceuticals Ltd., Under Fasting Condition in Adult Healthy Subjects.
- ClinicalTrials.gov ID
- NCT07746908
- Acronym / sponsor ID
- (BABE) / CB(BABE)-048-SAV(V)-2023
- Conditions
- Healthy Participants
- Keywords
- Bioequivalence, Sacubitril, Valsartan, Pakistan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Center for Bioequivalence Studies and Clinical ResearchUniversity, hospital or other
- Collaborators
- SAMI Pharmaceuticals (Pvt.) Ltd.
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 5 Aug 2026 (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.
This study is to evaluate the bioequivalence of Valsatril (Sacubitril/Valsartan) tablet 50 mg versus Entresto 50 mg tablet in healthy Pakistani volunteers under Fasting condition.
Detailed description
This will be a randomized, open-label, single-center, single-dose, two-treatment, two-period, two sequence crossover bioequivalence study in healthy adult participants with at least a 7-day washout period between treatment administrations.
A sufficient number of participants were screened to randomize approximately 60 participants, Participants were randomly assigned to one of the two treatment sequences and receive a single dose of each treatments in each (of 2) periods following a crossover design.
Blood was sampled regularly at scheduled times for 48 hours following treatment in each period to assess the pharmacokinetic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, randomized, single-dose, two way cross-over study
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Valsatril®Oral administration of Valsatril (Sacubitril/Valsartan) 24/26 mg Tablet with 240 mL of ambient temperature water after at least 10 hours fast at their specified dosing time-points. |
| Reference Group | Active comparator | Drug: Entresto®Oral administration of Entresto (Sacubitril/Valsartan) 24/26 mg Tablet with 240 mL of ambient temperature water after at least 10 hours fast at their specified dosing time-points. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy volunteers aged 18 to 55 years inclusive.
- Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive).
- Subjects who are healthy as determined by routine physical examination, including vital sign monitoring and laboratory analysis (i.e., hematology, blood biochemistry, and urinalysis).
- Subjects should have negative urine test for drugs of abuse and alcohol breath analysis at screening and prior to each check-in.
- All subjects should be free from any epidemic or contagious diseases (e.g., Malaria, Dengue, Covid-19)
Key exclusion criteria (12 listed)
- Inability to take oral medication
- History of smoking (≤3 cigarette/day), alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological /connective tissue, musculoskeletal, metabolic/nutritional, endocrine, allergy, or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication..
- Known hypersensitivity to any xenobiotic and Sacubitril/Valsartan or any of the excipients.
- A prior history of angioedema due to an ACEI or ARB.
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 |
|---|---|---|
| Valsatril®Also: Angiotensin Receptor-Neprilysin Inhibitor (ARNI)(Sacubitril/Valsartan) 24 mg/26 mg tablet of SAMI Pharmaceuticals (Pvt) Ltd | Drug | Test Group |
| Entresto®Also: Angiotensin Receptor-Neprilysin Inhibitor (ARNI)Entresto® (Sacubitril/Valsartan) 24 mg/26 mg tablet of Novartis Pharmaceuticals Ltd | Drug | Reference Group |
Primary outcome
AUC
Time frame: 0-48 hours post dose
Area under the plasma drug concentration time curve
Cmax
Time frame: 0 - 48 hours post dose
Maximum Plasma Concentration
5 secondary outcomes
Tmax,
Time frame: 0-48 hours post dose
t1/2
Time frame: 0-48 hours post dose
Blood Pressure
Time frame: 0-48 hours post dose
Body temperature
Time frame: 0-48 hours post dose
Heart rate.
Time frame: 0-48 hours post dose
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 Aug 2026.
- 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.
Dr. M. Raza Shah principal investigator
Center for Bioequivalence Studies and Clinical Research
Dr. Naghma Hashmi principal investigator
Center for Bioequivalence Studies and Clinical Research
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 Valsatril® and Entresto® in people with Healthy Participants, run by Center for Bioequivalence Studies and Clinical Research at 1 site in Pakistan.
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 8 inclusion and 12 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 Aug 2026. 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 Pakistan. 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?
AUC (time frame: 0-48 hours post dose). 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 Aug 2026.