HealthyPhase 1NCT02707913
Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations
A Phase 1 study testing BF-Amlodipine Tablet 10mg and Norvasc Tablet 10mg 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 amlodipine 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-Amlodipine Tablet 10mg and Norvasc Tablet 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Sep 2016
- 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
- Body Mass Index between 18 to 27
- Accessible vein for blood sampling
- High probability for compliance and completion of the study
- No significant abnormalities in general physical examination
- Electrocardiogram (ECG) recording within normal limits
- Biochemical and haematological parameters within normal limits
- Subjects must agree to take effective contraceptive methods to prevent pregnancy from the start of screening until two weeks of last dose administration
Who cannot join
- History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
- Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry and 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 amlodipine 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 amlodipine or other drugs in its class
- History of drug abuse in any form
- Female subjects who are breastfeeding or pregnant
About this study
The purpose of the study is to compare the bioavailability of a generic product of amlodipine with that of a reference product when administered to healthy volunteers under fasting conditions. The test product name is BF-Amlodipine Tablet 10mg manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Norvasc Tablet 10mg. The plasma pharmacokinetic data of amlodipine 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 crossover with a washout period of two to three weeks. During each session, the subjects will be administered a single oral dose of 10mg amlodipine (one BF-Amlodipine Tablet 10mg or one Norvasc Tablet 10mg) after an overnight fast of approximately 10 hours. Venous blood samples will be collected at pre-dose (0 h), and up to 96 h post dose. The plasma concentrations of amlodipine 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 Peak plasma concentration (Cmax), Time to maximum concentration (Tmax), Area under the plasma concentration versus time curve (AUC0-last, AUC0-inf) and Elimination half-life (T1/2). Analysis of Variance (ANOVA) will be conducted 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-Amlodipine Tablet 10mg, Norvasc Tablet 10mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BF-Amlodipine Tablet 10mgDrug
Also called Amlodipine Tablet 10mg
BF-Amlodipine Tablet 10mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Norvasc Tablet 10mgDrug
Also called Amlodipine Tablet 10mg
Norvasc Tablet 10mg will be used as a comparator drug for the BE study
| Study group | Role | What they receive |
|---|---|---|
| BF-Amlodipine Tablet 10mg | Experimental | During the study session, healthy subjects will be administered a single dose of BF-Amlodipine Tablet 10mg after an overnight fast of approximately 10 hours Receives: Drug: BF-Amlodipine Tablet 10mg |
| Norvasc Tablet 10mg | Active comparator | During the study session, healthy subjects will be administered a single dose of Norvasc Tablet 10mg after an overnight fast of approximately 10 hours Receives: Drug: Norvasc Tablet 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of amlodipine
Measured: 96 hours
Area under the plasma concentration versus time curve (AUC) of amlodipine
Measured: 96 hours
Secondary outcomes (2)
Time to maximum concentration (Tmax) of amlodipine
Measured: 96 hours
Elimination half-life (t1/2) of amlodipine)
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionSep 2016
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
- Allocation
- Randomised
- Intervention model
- 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 Univesity of Hong KongRisa Ozaki, Study director, Phase 1 Clinical Trial Centre, The Chinese University of Hong KongBrian Tomlinson, Study director, Dept. of Medicine and Therapeutics, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707913
- Sponsor's protocol ID
- BABE-P15-097
- Status last verified
- Sep 2016
- First submitted
- 10 Mar 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Study investigators and his/her study team members, domestic and foreign regulatory agencies, the Institutional Review Board/Ethics Committee (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 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Bioequivalence Study on Two Amlodipine Tablet 10mg Formulations
- ClinicalTrials.gov ID
- NCT02707913
- Acronym / sponsor ID
- BABE-P15-097
- 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
- Mar 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Mar 2016 (estimated)
- 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 amlodipine with that of a reference product when administered to healthy volunteers under fasting conditions. The test product name is BF-Amlodipine Tablet 10mg manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited, and the reference product is Norvasc Tablet 10mg. The plasma pharmacokinetic data of amlodipine 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 crossover with a washout period of two to three weeks. During each session, the subjects will be administered a single oral dose of 10mg amlodipine (one BF-Amlodipine Tablet 10mg or one Norvasc Tablet 10mg) after an overnight fast of approximately 10 hours. Venous blood samples will be collected at pre-dose (0 h), and up to 96 h post dose. The plasma concentrations of amlodipine 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 Peak plasma concentration (Cmax), Time to maximum concentration (Tmax), Area under the plasma concentration versus time curve (AUC0-last, AUC0-inf) and Elimination half-life (T1/2). Analysis of Variance (ANOVA) will be conducted 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BF-Amlodipine Tablet 10mg | Experimental | Drug: BF-Amlodipine Tablet 10mgDuring the study session, healthy subjects will be administered a single dose of BF-Amlodipine Tablet 10mg after an overnight fast of approximately 10 hours |
| Norvasc Tablet 10mg | Active comparator | Drug: Norvasc Tablet 10mgDuring the study session, healthy subjects will be administered a single dose of Norvasc Tablet 10mg 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 (7 listed)
- Body Mass Index between 18 to 27
- Accessible vein for blood sampling
- High probability for compliance and completion of the study
- No significant abnormalities in general physical examination
- Electrocardiogram (ECG) recording within normal limits
Key exclusion criteria (11 listed)
- History of hepatic, renal, biliary, cardiovascular, gastrointestinal, haematological and other chronic and acute diseases within 3 months prior to the study
- Clinically relevant abnormality in physical examination, ECG evaluation, urine test, blood chemistry and 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-Amlodipine Tablet 10mgAlso: Amlodipine Tablet 10mgBF-Amlodipine Tablet 10mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited | Drug | BF-Amlodipine Tablet 10mg |
| Norvasc Tablet 10mgAlso: Amlodipine Tablet 10mgNorvasc Tablet 10mg will be used as a comparator drug for the BE study | Drug | Norvasc Tablet 10mg |
Primary outcome
Peak plasma concentration (Cmax) of amlodipine
Time frame: 96 hours
Area under the plasma concentration versus time curve (AUC) of amlodipine
Time frame: 96 hours
2 secondary outcomes
Time to maximum concentration (Tmax) of amlodipine
Time frame: 96 hours
Elimination half-life (t1/2) of amlodipine)
Time frame: 96 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 7 Sep 2016.
- Individual participant dataSharing planned: No. Study investigators and his/her study team members, domestic and foreign regulatory agencies, the Institutional Review Board/Ethics Committee (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 Univesity of Hong Kong
Risa Ozaki study director
Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong
Brian Tomlinson study director
Dept. 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-Amlodipine Tablet 10mg and Norvasc Tablet 10mg 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 7 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 7 Sep 2016. 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?
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?
Peak plasma concentration (Cmax) of amlodipine (time frame: 96 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 7 Sep 2016; AzTrials last refreshed its copy on 4 Nov 2026.