HealthyPhase 1NCT03082352
Clinical Bioequivalence Study on Two Metoprolol Tablet 100mg Formulations
A Phase 1 study testing BF-Metoprolol Tablet 100mg and Betaloc Tablet 100mg in people with Healthy, run by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited.
Trial summary
The purpose of the study is to compare the bioavailability of a generic product of metoprolol with that of a reference product when administered to healthy volunteers under fasting conditions. 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-Metoprolol Tablet 100mg and Betaloc Tablet 100mg
- 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
- Aug 2020to Dec 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 metoprolol within 4 weeks before the study
Show all 11Show fewer
- Use of antihypertensive medications or other beta blockers within 4 weeks before the study
- Volunteer in any other clinical drug study within 2 months prior to this study
- Hypersensitivity to metoprolol 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 purpose of the study is to compare the bioavailability of a generic product of metoprolol with that of a reference product when administered to healthy volunteers under fasting conditions. The test product is BF-Metoprolol Tablets 100mg manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited and the reference product is Betaloc Tablet 100mg. The plasma kinetic data of metoprolol obtained from two formulations will be used to access the interchangeability of the products.
Read the detailed description
The study design is a single-dose, two-treatment, two-period, two-sequence cross over with a washout period of one to two weeks. Subject will be randomly assigned to two groups corresponding to two dosing sequences. Each subject will undergo two study (treatment) sessions, during which a single oral dose of 100mg metoprolol from either test or reference formulations will be administered. The estimated duration of subject's participation will be about 29-36 days (i.e. 3 weeks for screening and medication restraint, 1 day each for study (treatment) sessions I and II, 1 - 2 weeks as washout period. Venous blood samples will be collected at pre-dose (0h), and up to 24h post dose. The plasma concentrations of metoprolol 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-Metoprolol Tablet 100mg, Betaloc Tablet 100mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BF-Metoprolol Tablet 100mgDrug
Also called Metoprolol Tablet 100mg
BF-Metoprolol Tablet 100mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Betaloc Tablet 100mgDrug
Also called Metoprolol Tablet 100mg
Betaloc Tablet 100mg will be used as a comparator drug for the BE study
| Study group | Role | What they receive |
|---|---|---|
| BF-Metoprolol Tablet 100mg | Experimental | During the study session, healthy subjects will be administered a single dose of BF-Metoprolol Tablet 100mg after an overnight fast of approximately 10 hours Receives: Drug: BF-Metoprolol Tablet 100mg |
| Betaloc Tablet 100mg | Active comparator | During the study session, healthy subjects will be administered a single dose of Betaloc Tablet 100mg after an overnight fast of approximately 10 hours Receives: Drug: Betaloc Tablet 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of metoprolol
Measured: 24 hours
Area under the plasma concentration versus time curve (AUC) of metoprolol
Measured: 24 hours
Secondary outcomes (2)
Time to maximum concentration (Tmax) of metoprolol
Measured: 24 hours
Elimination half-life (t1/2) of metoprolol
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study startAug 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionDec 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
- NCT03082352
- Sponsor's protocol ID
- BABE-P15-100
- Status last verified
- Jul 2019
- First submitted
- 12 Mar 2017
- Last updated
- 29 Jul 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, the IRB/EC involved in the study, and laboratories and other individuals and organizations that analyze the subjects' protected health information in connection with this study have access to the data or study
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Bioequivalence Study on Two Metoprolol Tablet 100mg Formulations
- ClinicalTrials.gov ID
- NCT03082352
- Acronym / sponsor ID
- BABE-P15-100
- 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
- Aug 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Mar 2017 (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 purpose of the study is to compare the bioavailability of a generic product of metoprolol with that of a reference product when administered to healthy volunteers under fasting conditions. The test product is BF-Metoprolol Tablets 100mg manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited and the reference product is Betaloc Tablet 100mg. The plasma kinetic data of metoprolol obtained from two formulations will be used to access the interchangeability of the products.
Detailed description
The study design is a single-dose, two-treatment, two-period, two-sequence cross over with a washout period of one to two weeks. Subject will be randomly assigned to two groups corresponding to two dosing sequences. Each subject will undergo two study (treatment) sessions, during which a single oral dose of 100mg metoprolol from either test or reference formulations will be administered. The estimated duration of subject's participation will be about 29-36 days (i.e. 3 weeks for screening and medication restraint, 1 day each for study (treatment) sessions I and II, 1 - 2 weeks as washout period. Venous blood samples will be collected at pre-dose (0h), and up to 24h post dose. The plasma concentrations of metoprolol 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-Metoprolol Tablet 100mg | Experimental | Drug: BF-Metoprolol Tablet 100mgDuring the study session, healthy subjects will be administered a single dose of BF-Metoprolol Tablet 100mg after an overnight fast of approximately 10 hours |
| Betaloc Tablet 100mg | Active comparator | Drug: Betaloc Tablet 100mgDuring the study session, healthy subjects will be administered a single dose of Betaloc Tablet 100mg 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-Metoprolol Tablet 100mgAlso: Metoprolol Tablet 100mgBF-Metoprolol Tablet 100mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited | Drug | BF-Metoprolol Tablet 100mg |
| Betaloc Tablet 100mgAlso: Metoprolol Tablet 100mgBetaloc Tablet 100mg will be used as a comparator drug for the BE study | Drug | Betaloc Tablet 100mg |
Primary outcome
Peak plasma concentration (Cmax) of metoprolol
Time frame: 24 hours
Area under the plasma concentration versus time curve (AUC) of metoprolol
Time frame: 24 hours
2 secondary outcomes
Time to maximum concentration (Tmax) of metoprolol
Time frame: 24 hours
Elimination half-life (t1/2) of metoprolol
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Individual participant dataSharing planned: Yes. Study investigators and his/her study team members, domestic and foreign regulatory agencies, the IRB/EC involved in the study, and laboratories and other individuals and organizations that analyze the subjects' protected health information in connection with this study have access to the data or study
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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-Metoprolol Tablet 100mg and Betaloc Tablet 100mg 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 29 Jul 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, bfok@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 metoprolol (time frame: 24 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 29 Jul 2019.