HealthyPhase 1NCT03210025
Clinical Bioequivalence Study on Two Methyldopa Tablet 250mg Formulations
A Phase 1 study testing BF-Methyldopa 250mg Tablet and Metopa Tab 250mg in people with Healthy, run by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited at 1 site in Hong Kong.
Trial summary
The objective of the study is to compare the bioavailability of a generic product of methyldopa with that of a reference product when administered to healthy volunteers under fasting condition. The test product is BF-Methyldopa Tablet 250mg (HK Reg. No. 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-Methyldopa 250mg Tablet and Metopa Tab 250mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Sep 2017to 15 Oct 2017
- 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 27 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 screening until two weeks of last dose administration.
Who cannot join
- Clinical significant hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
- Clinical significant abnormality in physical examination, vital signs, ECG evaluation, urine test, blood chemistry or haematological test
- Tobacco use in any forms
- Regular consumer of alcohol
- Blood donation within 4 weeks prior to the start of the study
- Use of Methyldopa within 4 weeks before the study
Show all 11Show fewer
- Use of antihypertensive medications within 4 weeks before the study
- Volunteer in any other clinical drug study within 2 months prior to this study
- Hypersensitivity to Methyldopa or other drugs in its class
- History of drug abuse in any form
- Female subjects who are breastfeeding or pregnant.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong
Hong Kong
About this study
The objective of the study is to compare the bioavailability of a generic product of methyldopa with that of a reference product when administered to healthy volunteers under fasting condition. The test product is BF-Methyldopa Tablet 250mg (HK Reg. No. HK-62917) manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Metopa Tab 250mg (HK Reg. No. HK-44620). The plasma pharmacokinetic data of Methyldopa obtained from two formulations will be used to access the interchangeability of the products.
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 oral dose of 250mg methyldopa (one BF-Methyldopa Tablet 250mg or one Metopa Tab 250mg) after an overnight fast of approximately 10 hours. Venous blood samples will be collected at pre-dose (0h) and at 0.75 (45min), 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours post-dose. The plasma concentrations of methyldopa 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. Anylasis of variance (ANOVA) will be conducted on logarithmically transformed Cmax, AUC0-last and AUC0-inf using the General Linear Model. The two one-side 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-Methyldopa 250mg Tablet, Metopa Tab 250mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BF-Methyldopa 250mg TabletDrug
Also called Methyldopa 250mg Tablet
BF-Methyldopa 250mg Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Metopa Tab 250mgDrug
Also called Methyldopa 250mg Tablet
Metopa Tab 250mg is manufactured by APT
| Study group | Role | What they receive |
|---|---|---|
| BF-Methyldopa Tablet 250mg | Experimental | During the study session, healthy subjects will be administered a single dose of BF-Methyldopa Tablet 250mg after an overnight fast of approximately 10 hours Receives: Drug: BF-Methyldopa 250mg Tablet |
| Metopa Tab 250mg | Active comparator | During the study session, healthy subjects administered a single dose of Metopa Tablet 250mg after an overnight fast of approximately 10 hours Receives: Drug: Metopa Tab 250mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Methyldopa
Measured: 24 hours
AUC of Methyldopa
Measured: 24 hours
Secondary outcomes (2)
Tmax of Methyldopa
Measured: 24 hours
Elimination half-life (t1/2) of Methyldopa
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 posted6 Jul 2017
- Study start20 Sep 2017
- Primary completion15 Oct 2017
- Study completion15 Oct 2017
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
- Model description
- Single-dose, two-treatment, two-period, two-sequence crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
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
- NCT03210025
- Sponsor's protocol ID
- BABE-P15-096
- Status last verified
- Jan 2018
- First submitted
- 3 Jul 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Bioequivalence Study on Two Methyldopa Tablet 250mg Formulations
- ClinicalTrials.gov ID
- NCT03210025
- Acronym / sponsor ID
- BABE-P15-096
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Chinese University of Hong Kong
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- 15 Oct 2017 (actual)
- First posted
- 6 Jul 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 objective of the study is to compare the bioavailability of a generic product of methyldopa with that of a reference product when administered to healthy volunteers under fasting condition. The test product is BF-Methyldopa Tablet 250mg (HK Reg. No. HK-62917) manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Metopa Tab 250mg (HK Reg. No. HK-44620). The plasma pharmacokinetic data of Methyldopa obtained from two formulations will be used to access the interchangeability of the products.
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 oral dose of 250mg methyldopa (one BF-Methyldopa Tablet 250mg or one Metopa Tab 250mg) after an overnight fast of approximately 10 hours. Venous blood samples will be collected at pre-dose (0h) and at 0.75 (45min), 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 hours post-dose. The plasma concentrations of methyldopa 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. Anylasis of variance (ANOVA) will be conducted on logarithmically transformed Cmax, AUC0-last and AUC0-inf using the General Linear Model. The two one-side 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
- Model description
- Single-dose, two-treatment, two-period, two-sequence crossover
| Arm | Type | Receives |
|---|---|---|
| BF-Methyldopa Tablet 250mg | Experimental | Drug: BF-Methyldopa 250mg TabletDuring the study session, healthy subjects will be administered a single dose of BF-Methyldopa Tablet 250mg after an overnight fast of approximately 10 hours |
| Metopa Tab 250mg | Active comparator | Drug: Metopa Tab 250mgDuring the study session, healthy subjects administered a single dose of Metopa Tablet 250mg 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 27 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 screening until two weeks of last dose administration.
Key exclusion criteria (11 listed)
- Clinical significant hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
- Clinical significant abnormality in physical examination, vital signs, ECG evaluation, urine test, blood chemistry or haematological test
- Tobacco use in any forms
- Regular consumer of alcohol
- 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-Methyldopa 250mg TabletAlso: Methyldopa 250mg TabletBF-Methyldopa 250mg Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited | Drug | BF-Methyldopa Tablet 250mg |
| Metopa Tab 250mgAlso: Methyldopa 250mg TabletMetopa Tab 250mg is manufactured by APT | Drug | Metopa Tab 250mg |
Primary outcome
Cmax of Methyldopa
Time frame: 24 hours
AUC of Methyldopa
Time frame: 24 hours
2 secondary outcomes
Tmax of Methyldopa
Time frame: 24 hours
Elimination half-life (t1/2) of Methyldopa
Time frame: 24 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 18 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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
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 BF-Methyldopa 250mg Tablet and Metopa Tab 250mg in people with Healthy, run by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited at 1 site in Hong Kong.
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: finished, as of the sponsor's last update on 18 Jan 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 Hong Kong. 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?
Cmax of Methyldopa (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 18 Jan 2018.