HealthyPhase 1NCT03459911
A Bioequivalence Study of Losartan Potassium Tablets (Containing Losartan Potassium 100 mg) in Normal, Healthy, Adults Under Fasting Conditions
A Phase 1 study testing Cozaar 100mg Tablet and Losartan potassium 100mg in people with Healthy, run by Pharmtechnology LLC at 1 site in India.
Trial summary
To demonstrate bioequivalence of single dose test formulation of Losartan potassium tablets (containing Losartan potassium 100 mg) of Pharmtechnology LLC, Republic of Belarus with reference Cozaar® (containing Losartan potassium 100 mg) of "Merck Sharpe \& Dohme B.V.", Haarlem, the Netherlands in normal, healthy… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cozaar 100mg Tablet and Losartan potassium 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIndia
- Study dates
- 16 Feb 2018to 16 Mar 2018
- 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
- The following criteria should be checked at the time of study entry. If any does not apply at the time of study entry, the subject must not be included in the study:
- Healthy adult human subjects, aged between 18 to 45 years (both inclusive).
- Subjects with Body Mass Index (BMI) 18.5 to 24.9 kg/m2
- Subjects able and willing to comply with the protocol requirements.
- Subjects should not have any medical history of significant diseases.
- If subject is a female and is
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- of child bearing potential, she should be practicing an acceptable method of birth control for the duration of the study as suggested by the investigator, such as a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier method), intrauterine device (IUD), or abstinence.
- OR
- surgically sterile, bilateral tubal ligation done at least 6 months before the study should be documented.
- Subjects willing to voluntarily provide written informed consent.
- Subjects willing to undergo pre- and post-study physical examinations and laboratory investigations.
- Subjects who are non-smokers based on history.
- Subjects willing to adhere to the protocol and the following study requirements:
- Should not consume xanthine containing products, such as coffee, tea, chocolate or soft drinks at least 48 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) until the last sample collection.
- Should not consume alcohol at least 48 hours prior to dosing (i.e. during in-house monitoring and the remaining based on history) until the last sample collection.
- Should not consume grapefruit or its products at least 7 days prior to each dosing (i.e. during in-house monitoring and the remaining based on history) and until the last sample collection.
- Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments, 12-lead ECG, chest X-Ray or vital signs.
Who cannot join
- The following criteria should be checked at the time of study entry. If any of these apply at the time of study entry, the subject must not be included in the study:
- Subjects incapable of understanding the informed consent process.
- Female subjects with a positive pregnancy test at screening or positive serum β-HCG test (done at check-in of each study periods) or lactating females.
- Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria, at least 28 days prior to the first period dosing until the post-study follow-up (i.e. until 7 days from the drug administration in Period II). Use of hormonal contraceptives either oral or implants within 3 months prior to first period dosing will not be acceptable.
- Subjects with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study.
- Subjects with abnormalities in resting heart rate (>100 beats/min or <50 beats/min), blood pressure either hypotensive episode (systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg) or hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥90 mmHg), oral temperature (< 95.60F or > 990F) on the screening day.
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- Subjects with history of psychiatric disorders, which are likely to limit the validity of consent to participate in the study, or limit the ability to comply with the protocol requirements.
- Subjects with any evidence of organ dysfunction or any clinically significant deviation from normal in their physical or clinical evaluation including ECG and X-ray results.
- Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within 30 days prior to the start of the clinical period and during the study period.
- Subjects with a known history of drug hypersensitivity to losartan or any excipients of the formulation.
- Subjects with a history of alcohol abuse and/or drug abuse or who are found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates) or are found with current alcohol abuse based on alcohol breath test.
- Subjects diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
- Subjects with clinically significant abnormal haematological values [haemoglobin (Hb), total white blood cells count (WBC), total red blood cells count (RBC), differential WBC count, platelet count and hematocrit].
- Subjects with clinically significant abnormal laboratory values for serum creatinine, blood urea nitrogen (BUN), serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase (ALP), serum bilirubin, serum glucose (fasting), and serum cholesterol.
- Subjects with clinically significant abnormal urine analysis, defined as the presence of RBC (>5/HPF), pus cells (>5/HPF), epithelial cells (>5/HPF), glucose (positive), ketones (positive), bilirubin (positive) and protein (positive) (unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study).
- Subjects with a clinically significant past history or current medical condition of:
- Pulmonary disorders (COPD and asthma)
- Cardiovascular disorders (especially heart blocks, myocardial infarction, congestive heart failure and uncontrolled hypertension)
- Neurological disorders (especially epileptic seizures)
- GIT disorders (gastrointestinal bleeding, gastric/peptic ulcer)
- Renal and/or hepatic disorders
- Coagulation disorders
- Endocrine disorders (especially diabetes mellitus)
- Any history of difficulty in donating blood
- Any clinically significant illness during 3 months before screening.
- Subjects who participated in any other clinical investigation using experimental drugs or have bled more than 300 mL in the past 3 months
Trial locations and contacts
1 site in 1 country.
India1 site
Clinical Unit, Reliance Life Sciences Pvt. Ltd.
Mumbai, Maharashtra, 400 701
About this study
Official title: A Randomized, Open-label, Single-dose, Two-treatment, Two-sequence, Two-period, Crossover Bioequivalence Study of Test Losartan Potassium Tablets (Containing Losartan Potassium 100 mg) of Pharmtechnology LLC, Republic of Belarus With Reference Cozaar® (Containing Losartan Potassium 100 mg) of "Merck Sharpe & Dohme B.V.", Haarlem, the Netherlands in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions
To demonstrate bioequivalence of single dose test formulation of Losartan potassium tablets (containing Losartan potassium 100 mg) of Pharmtechnology LLC, Republic of Belarus with reference Cozaar® (containing Losartan potassium 100 mg) of "Merck Sharpe \& Dohme B.V.", Haarlem, the Netherlands in normal, healthy, adult, human subjects under fasting conditions.To monitor adverse events and ensure the safety
Read the detailed description
Total 66 normal healthy adult subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 200 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to administration of the study drugs and for four (4) hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour to administration of the study drugs and 1 hour after administration of the study drugs in each period. A total of 29 blood samples will be withdrawn for pharmacokinetic profiling during each study period. The plasma concentrations of losartan and its carboxylic acid metabolite will be measured by a validated LC-MS/MS analytical method. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-t, AUC0-∞, and 90% confidence interval will be constructed for the ratio of geometric least square mean of the Test and Reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval, both falls within the acceptable range of 80.00% to 125.00% for Cmax, AUC0-t.
- Conditions
- Healthy
- Being tested
- Cozaar 100mg Tablet, Losartan potassium 100mg
- Keywords
- Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cozaar 100mg TabletDrug
Cozaar® ( Losartan potassium) 100 mg Tablets(Merck Sharpe \& Dohme B.V. , Haarlem, the Netherlands)
Losartan potassium 100mgDrug
Losartan potassium 100 mg Tablets ( Pharmtechnology LLC, Republic of Belarus)
| Study group | Role | What they receive |
|---|---|---|
| Losartan potassium 100 mg Tablets | Experimental | Losartan potassium is the test product. In period 1 and period 2, 33 of 66 subjects will be given single oral dose (1 x 100 mg) of Losartan potassium. Receives: Drug: Losartan potassium 100mg |
| Cozaar® (Losartan potassium)100 mg Tablets | Active comparator | Cozaar® (Losartan potassium) is the reference product. In period 1 and period 2, 33 of 66 subjects will be given single oral dose (1 x 100 mg) of Cozaar®. Receives: Drug: Cozaar 100mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter for losartan
Peak Plasma Concentration (Cmax)
Measured: 10 Days
Pharmacokinetic parameter for losartan
Area under the plasma concentration versus time curve from time 0 to the last measured concentration (AUC0-t)
Measured: 10 Days
Secondary outcomes (6)
Safety and tolerability of investigational products
Number of adverse events, number of deaths, number of severe adverse events in subjects who have taken at least one dose of investigational products.
Measured: 17 Days
Other pharmacokinetic parameters for losartan
Area under the plasma concentration versus time curve from time 0 to to infinite time(AUC0-∞)
Measured: 10 Days
Other pharmacokinetic parameters for losartan
Time of maximum measured plasma concentration (Tmax)
Measured: 10 Days
Other pharmacokinetic parameters for losartan
Elimination or terminal half-life (T1/2)
Measured: 10 Days
Other pharmacokinetic parameters for losartan
Elimination rate constant (Kel)
Measured: 10 Days
Other pharmacokinetic parameters for losartan
Residual area (AUCresid)
Measured: 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start16 Feb 2018
- Primary completion11 Mar 2018
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmtechnology LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Reliance Life Sciences Private Limited
- Responsible party
- Sponsor
- Investigators
- Suresh A Maroli, MD, Principal investigator, Reliance Life Sciences Pvt. Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459911
- Sponsor's protocol ID
- RLS/1117/046
- Status last verified
- Jun 2018
- First submitted
- 27 Feb 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Company may provide the individual participant data after privacy protection on case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Two-treatment, Two-sequence, Two-period, Crossover Bioequivalence Study of Test Losartan Potassium Tablets (Containing Losartan Potassium 100 mg) of Pharmtechnology LLC, Republic of Belarus With Reference Cozaar® (Containing Losartan Potassium 100 mg) of "Merck Sharpe & Dohme B.V.", Haarlem, the Netherlands in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT03459911
- Acronym / sponsor ID
- RLS/1117/046
- Conditions
- Healthy
- Keywords
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Pharmtechnology LLCIndustry (pharma, biotech, devices)
- Collaborators
- Reliance Life Sciences Private Limited
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 11 Mar 2018 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 9 Mar 2018 (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 demonstrate bioequivalence of single dose test formulation of Losartan potassium tablets (containing Losartan potassium 100 mg) of Pharmtechnology LLC, Republic of Belarus with reference Cozaar® (containing Losartan potassium 100 mg) of "Merck Sharpe \& Dohme B.V.", Haarlem, the Netherlands in normal, healthy, adult, human subjects under fasting conditions.To monitor adverse events and ensure the safety
Detailed description
Total 66 normal healthy adult subjects will be enrolled in the study. Subjects will be administered either the Test or the Reference Product with 200 mL of water in each period as per the randomization schedule. Subjects will fast for at least 10 hours prior to administration of the study drugs and for four (4) hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the subjects 1 hour to administration of the study drugs and 1 hour after administration of the study drugs in each period. A total of 29 blood samples will be withdrawn for pharmacokinetic profiling during each study period. The plasma concentrations of losartan and its carboxylic acid metabolite will be measured by a validated LC-MS/MS analytical method. ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, AUC0-t, AUC0-∞, and 90% confidence interval will be constructed for the ratio of geometric least square mean of the Test and Reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval, both falls within the acceptable range of 80.00% to 125.00% for Cmax, AUC0-t.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan potassium 100 mg Tablets | Experimental | Drug: Losartan potassium 100mgLosartan potassium is the test product. In period 1 and period 2, 33 of 66 subjects will be given single oral dose (1 x 100 mg) of Losartan potassium. |
| Cozaar® (Losartan potassium)100 mg Tablets | Active comparator | Drug: Cozaar 100mg TabletCozaar® (Losartan potassium) is the reference product. In period 1 and period 2, 33 of 66 subjects will be given single oral dose (1 x 100 mg) of Cozaar®. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- The following criteria should be checked at the time of study entry. If any does not apply at the time of study entry, the subject must not be included in the study:
- Healthy adult human subjects, aged between 18 to 45 years (both inclusive).
- Subjects with Body Mass Index (BMI) 18.5 to 24.9 kg/m2
- Subjects able and willing to comply with the protocol requirements.
- Subjects should not have any medical history of significant diseases.
Key exclusion criteria (26 listed)
- The following criteria should be checked at the time of study entry. If any of these apply at the time of study entry, the subject must not be included in the study:
- Subjects incapable of understanding the informed consent process.
- Female subjects with a positive pregnancy test at screening or positive serum β-HCG test (done at check-in of each study periods) or lactating females.
- Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria, at least 28 days prior to the first period dosing until the post-study follow-up (i.e. until 7 days from the drug administration in Period II). Use of hormonal contraceptives either oral or implants within 3 months prior to first period dosing will not be acceptable.
- Subjects with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study.
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 |
|---|---|---|
| Cozaar 100mg TabletCozaar® ( Losartan potassium) 100 mg Tablets(Merck Sharpe \& Dohme B.V. , Haarlem, the Netherlands) | Drug | Cozaar® (Losartan potassium)100 mg Tablets |
| Losartan potassium 100mgLosartan potassium 100 mg Tablets ( Pharmtechnology LLC, Republic of Belarus) | Drug | Losartan potassium 100 mg Tablets |
Primary outcome
Pharmacokinetic parameter for losartan
Time frame: 10 Days
Peak Plasma Concentration (Cmax)
Pharmacokinetic parameter for losartan
Time frame: 10 Days
Area under the plasma concentration versus time curve from time 0 to the last measured concentration (AUC0-t)
6 secondary outcomes
Safety and tolerability of investigational products
Time frame: 17 Days
Other pharmacokinetic parameters for losartan
Time frame: 10 Days
Other pharmacokinetic parameters for losartan
Time frame: 10 Days
Other pharmacokinetic parameters for losartan
Time frame: 10 Days
Other pharmacokinetic parameters for losartan
Time frame: 10 Days
Other pharmacokinetic parameters for losartan
Time frame: 10 Days
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 2 Nov 2018.
- Individual participant dataSharing planned: Undecided. The Company may provide the individual participant data after privacy protection on case by case basis.
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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.
Suresh A Maroli, MD principal investigator
Reliance Life Sciences Pvt. Ltd
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 Cozaar 100mg Tablet and Losartan potassium 100mg in people with Healthy, run by Pharmtechnology LLC 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 17 inclusion and 26 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 2 Nov 2018. 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?
Pharmacokinetic parameter for losartan (time frame: 10 Days). 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 2 Nov 2018.