HealthyPhase 1NCT03599466
Clinical Bioequivalence Study on Two Lisinopril Tablets 20mg Formulations
A Phase 1 study testing BF-Lisinopril Tablets 20mg and Zestril Tab 20mg in people with Healthy, run by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited.
Trial summary
The objective of the study is to compare the bioavailability of a generic product of lisinopril with that of a reference product when administered to healthy volunteers under fasting condition. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BF-Lisinopril Tablets 20mg and Zestril Tab 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Apr 2020
- 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
- Male and non-pregnant female, 18 to 55 years of age
- Body Mass Index between 18 to 30 kg/m2
- Accessible vein for blood sampling
- High probability for compliance and completion of the study
- Female subjects must agree to practice abstinence or take effective contraceptive methods to prevent pregnancy from the start of the screening and until two weeks of last dose administration.
Who cannot join
- Clinically significant hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
- Clinically significant abnormality in physical examination, vital sign, laboratory test results, ECG evaluation, urine test, blood chemistry or haematological test
- Regular consumption of tobacco used in any forms
- Regular consumer of alcohol (more than one drink per day)
- Blood donation within 4 weeks prior to the start of the study
- Use of lisinopril within 4 weeks before the study
Show all 11Show fewer
- Use of antihypertensive medications or angiotensin-converting enzyme (ACE) inhibitors within 4 weeks before the study
- Volunteer in any other clinical drug study within 2 months prior to this study
- Hypersensitivity to lisinopril or other drugs in its class
- History of drug abuse in any form
- Female subjects who are breastfeeding or pregnant
Trial locations and contacts
No sites are listed yet.
About this study
The objective of the study is to compare the bioavailability of a generic product of lisinopril with that of a reference product when administered to healthy volunteers under fasting condition. The test product is BF-Lisinopril Tablet 20mg (HK-63564) manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Zestril Tab 20mg (HK-30515). The bioequivalence or bioinequivalence of the test and reference formulations will be assessed and concluded based on the plasma pharmacokinetic data of lisinopril, as well as WHO guidelines on registration requirements to establish interchangeability.
Read the detailed description
It is planned to enroll 16 to 30 healthy subjects, with an aim to obtain at least 12 evaluable subjects. The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a washout period of one to two weeks. During each study session, the subjects will be administered a single dose of 20mg lisinopril (one BF-Lisinopril tablets 20mg or one Zestril Tab 20mg) after an overnight fast of approximately 10 hours. Venous blood samples will be collected at pre-dose (0h) and at 1,2,4,5,6,7,8,9,10,12,24 and 48 hours post-dose (13 time points). The plasma concentrations of lisinopril will be determined by a validated assay. The non-compartmental method will be used to analyze the plasma concentration-time data and calculate the main pharmacokinetic parameters such as Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. ANOVA will be calculated on logarithmically transformed Cmax, AUC0-last and AUC0-inf. The two one sided tests will be used to calculate the 90% confidence intervals for the mean difference in AUC0-last, AUC0-inf and Cmax and to assess the bioequivalence of the two products.
- Conditions
- Healthy
- Being tested
- BF-Lisinopril Tablets 20mg, Zestril Tab 20mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BF-Lisinopril Tablets 20mgDrug
BF-Lisinopril Tablets 20mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Zestril Tab 20mgDrug
Zestril Tab 20mg will be used as a reference drug in this study
| Study group | Role | What they receive |
|---|---|---|
| BF-Lisinopril Tablets 20mg | Experimental | During the study session, the subjects will be administered a single dose of BF-Lisinopril Tablet 20mg after an overnight fast of approximately 10 hours. Receives: Drug: BF-Lisinopril Tablets 20mg; Drug: Zestril Tab 20mg |
| Zestril Tab 20mg | Active comparator | During the study session, the subjects will be administered a single dose of Zestril Tab 20mg after an overnight fast of approximately 10 hours. Receives: Drug: BF-Lisinopril Tablets 20mg; Drug: Zestril Tab 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of Lisinopril
Peak drug concentration, obtained directly from the original concentration-time data.
Measured: 48 hours
Area under the plasma concentration versus time curve (AUC) of Lisinopril
Area under the concentration-time curve from time zero to the last sampling time.
Measured: 48 hours
Secondary outcomes (2)
Time to maximum concentration (Tmax) of Lisinopril
Time to peak drug concentration, obtained directly from the original concentration-time data.
Measured: 48 hours
Elimination half-life (t1/2) of Lisinopril
Terminal elimination half-life, calculated as 0.693/(the terminal phase elimination rate constant that can be obtained using WinNonlin)
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 posted26 Jul 2018
- Study startOct 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionApr 2020 (estimated)
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Zhong Zuo, Principal investigator, School of Pharmacy, The Chinese University of Hong KongRiza Ozaki, Study director, Phase 1 Clinical Trial Centre, The Chinese University of Hong KongBrian Tomlinsion, Study director, Department of Medicine and Therapeutics, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599466
- Sponsor's protocol ID
- BABE-P15-099
- Status last verified
- Jan 2019
- First submitted
- 16 Jan 2018
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study investigators and his/her study team members, domestic and foreign regulatory agencies, members of ethics committee and health authorities, monitors and auditors relevant to conduct of this clinical study will be granted free access to subject's data. The relevant technical, medical, pharmaceutical, biological and chemical personnel of the sponsor will have access to the case report forms.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Bioequivalence Study on Two Lisinopril Tablets 20mg Formulations
- ClinicalTrials.gov ID
- NCT03599466
- Acronym / sponsor ID
- BABE-P15-099
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Chinese University of Hong Kong
- Study start
- Oct 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 26 Jul 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.
The objective of the study is to compare the bioavailability of a generic product of lisinopril with that of a reference product when administered to healthy volunteers under fasting condition. The test product is BF-Lisinopril Tablet 20mg (HK-63564) manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Zestril Tab 20mg (HK-30515). The bioequivalence or bioinequivalence of the test and reference formulations will be assessed and concluded based on the plasma pharmacokinetic data of lisinopril, as well as WHO guidelines on registration requirements to establish interchangeability.
Detailed description
It is planned to enroll 16 to 30 healthy subjects, with an aim to obtain at least 12 evaluable subjects. The study design is a single-dose, two-treatment, two-period, two-sequence crossover with a washout period of one to two weeks. During each study session, the subjects will be administered a single dose of 20mg lisinopril (one BF-Lisinopril tablets 20mg or one Zestril Tab 20mg) after an overnight fast of approximately 10 hours. Venous blood samples will be collected at pre-dose (0h) and at 1,2,4,5,6,7,8,9,10,12,24 and 48 hours post-dose (13 time points). The plasma concentrations of lisinopril will be determined by a validated assay. The non-compartmental method will be used to analyze the plasma concentration-time data and calculate the main pharmacokinetic parameters such as Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. ANOVA will be calculated on logarithmically transformed Cmax, AUC0-last and AUC0-inf. The two one sided tests will be used to calculate the 90% confidence intervals for the mean difference in AUC0-last, AUC0-inf and Cmax and to assess the bioequivalence of the two products.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BF-Lisinopril Tablets 20mg | Experimental | Drug: BF-Lisinopril Tablets 20mg, Drug: Zestril Tab 20mgDuring the study session, the subjects will be administered a single dose of BF-Lisinopril Tablet 20mg after an overnight fast of approximately 10 hours. |
| Zestril Tab 20mg | Active comparator | Drug: BF-Lisinopril Tablets 20mg, Drug: Zestril Tab 20mgDuring the study session, the subjects will be administered a single dose of Zestril Tab 20mg after an overnight fast of approximately 10 hours. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and non-pregnant female, 18 to 55 years of age
- Body Mass Index between 18 to 30 kg/m2
- Accessible vein for blood sampling
- High probability for compliance and completion of the study
- Female subjects must agree to practice abstinence or take effective contraceptive methods to prevent pregnancy from the start of the screening and until two weeks of last dose administration.
Key exclusion criteria (11 listed)
- Clinically significant hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
- Clinically significant abnormality in physical examination, vital sign, laboratory test results, ECG evaluation, urine test, blood chemistry or haematological test
- Regular consumption of tobacco used in any forms
- Regular consumer of alcohol (more than one drink per day)
- Blood donation within 4 weeks prior to the start of 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 |
|---|---|---|
| BF-Lisinopril Tablets 20mgBF-Lisinopril Tablets 20mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited | Drug | BF-Lisinopril Tablets 20mg, Zestril Tab 20mg |
| Zestril Tab 20mgZestril Tab 20mg will be used as a reference drug in this study | Drug | BF-Lisinopril Tablets 20mg, Zestril Tab 20mg |
Primary outcome
Peak plasma concentration (Cmax) of Lisinopril
Time frame: 48 hours
Peak drug concentration, obtained directly from the original concentration-time data.
Area under the plasma concentration versus time curve (AUC) of Lisinopril
Time frame: 48 hours
Area under the concentration-time curve from time zero to the last sampling time.
2 secondary outcomes
Time to maximum concentration (Tmax) of Lisinopril
Time frame: 48 hours
Elimination half-life (t1/2) of Lisinopril
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: Yes. Study investigators and his/her study team members, domestic and foreign regulatory agencies, members of ethics committee and health authorities, monitors and auditors relevant to conduct of this clinical study will be granted free access to subject's data. The relevant technical, medical, pharmaceutical, biological and chemical personnel of the sponsor will have access to the case report forms.
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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.
Zhong Zuo principal investigator
School of Pharmacy, The Chinese University of Hong Kong
Riza Ozaki study director
Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong
Brian Tomlinsion study director
Department of Medicine and Therapeutics, The Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BF-Lisinopril Tablets 20mg and Zestril Tab 20mg in people with Healthy, run by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited.
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 5 inclusion and 11 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 16 Jan 2019. 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 Evelyn YM Chau ((852) 26323377, chauevelyn@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plasma concentration (Cmax) of Lisinopril (time frame: 48 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 16 Jan 2019.