BioequivalencePhase 1NCT02974439
Bioequivalence Study of Amlodipine and Norvasc Under Fasting and FED Conditions in Chinese Healthy Volunteers
A Phase 1 study testing LANDI-Amlodipine Besylate Tablet 5mg and Norvasc Tablets 5mg in people with Bioequivalence, run by Shanghai Haini Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5 mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a washout period of 14 days Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- LANDI-Amlodipine Besylate Tablet 5mg and Norvasc Tablets 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2016to 21 Mar 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers of 18-40 years old, male or female.
- Body mass index (BMI) ranges from 19.0 to 25.0 kg/m2, body weight ≥ 50 kg for male and 45 kg for female.
- No history of heart, liver, kidney, gastrointestinal tract diseases, nervous system, neural abnormities or metabolic abnormalities; No preparation allergies, serious infection or injury, etc.
- Medically healthy subjects with clinically normal laboratory profiles and ECGs.
- Subjects must agree to take effective contraceptive methods to prevent pregnancy from the start of screening until 3 months of last dose administration
- Subjects are fully informed and voluntarily consent to participate in this study.
Who cannot join
- History of allergy or hypersensitivity to amlodipine
- Significant history of neurological, cardiovascular, digestive, respiratory, urinary, hematological, dysmetabolism or other diseases (such as psychosis) which is unfavorable to the study
- History of postural hypotension
- Blood donation or lost more than 400mL blood within 3 months prior to the study
- Use of medications within 2 weeks before the study
- Volunteer in any other clinical drug study within 3 months prior to this study
Show all 12Show fewer
- Drug abuse or alcohol abuse (220ml beer /day or >5 times in 2 hours)
- Smoker (>10 cigarettes/day)
- A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test
- Abnormal chest X-ray results with clinical significance
- Women of childbearing potential, pregnant and lactating women.
- Other unfavorable factors diagnosed by investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study of Amlodipine and Norvasc Under Fasting Condition Sand Under Non-fasting(FED) Conditions in Chinese Healthy Volunteers
This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5 mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a washout period of 14 days
Read the detailed description
The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 14 days. During each session, the subjects will be administered a single dose of 5mg amlodipine (one LANDI-Amlodipine Tablet 5mg or one Norvasc Tablet 5mg) under fasting and FED conditions.
- Conditions
- Bioequivalence
- Being tested
- LANDI-Amlodipine Besylate Tablet 5mg, Norvasc Tablets 5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LANDI-Amlodipine Besylate Tablet 5mgDrug
Also called Amlodipine Tablet 5mg
LANDI-Amlodipine Besylate Tablet 5mg is a generic product manufactured by YangTZE River Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd.
Norvasc Tablets 5mgDrug
Also called Amlodipine Tablet 5mg
Norvasc Tablet 5mg will be used as a comparator drug for the BE study.
| Study group | Role | What they receive |
|---|---|---|
| LANDI-Amlodipine Besylate Tablet 5mg | Experimental | During the study session, healthy subjects will be administered a single dose of LANDI-AmlodipineTablet 5mg under fasting and FED conditions. Receives: Drug: LANDI-Amlodipine Besylate Tablet 5mg |
| Norvasc Tablets 5mg | Active comparator | During the study session, healthy subjects will be administered a single dose of Norvasc Tablets 5mg under fasting and FED conditions. Receives: Drug: Norvasc Tablets 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Peak Plasma Concentration (Cmax)
Measured: 144 hours
Secondary outcomes (1)
Bioequivalence based on Area under the plasma concentration versus time curves (AUC)
Measured: 144 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study start23 Dec 2016
- Primary completion21 Mar 2017
- Study completion21 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Haini Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanmei Liu, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974439
- Sponsor's protocol ID
- HN-LD
- Status last verified
- Oct 2017
- First submitted
- 17 Nov 2016
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study of Amlodipine and Norvasc Under Fasting Condition Sand Under Non-fasting(FED) Conditions in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02974439
- Acronym / sponsor ID
- HN-LD
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Haini Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2016 (actual)
- Primary completion
- 21 Mar 2017 (actual)
- Study completion
- 21 Mar 2017 (actual)
- First posted
- 28 Nov 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.
This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5 mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a washout period of 14 days
Detailed description
The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 14 days. During each session, the subjects will be administered a single dose of 5mg amlodipine (one LANDI-Amlodipine Tablet 5mg or one Norvasc Tablet 5mg) under fasting and FED conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LANDI-Amlodipine Besylate Tablet 5mg | Experimental | Drug: LANDI-Amlodipine Besylate Tablet 5mgDuring the study session, healthy subjects will be administered a single dose of LANDI-AmlodipineTablet 5mg under fasting and FED conditions. |
| Norvasc Tablets 5mg | Active comparator | Drug: Norvasc Tablets 5mgDuring the study session, healthy subjects will be administered a single dose of Norvasc Tablets 5mg under fasting and FED conditions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult volunteers of 18-40 years old, male or female.
- Body mass index (BMI) ranges from 19.0 to 25.0 kg/m2, body weight ≥ 50 kg for male and 45 kg for female.
- No history of heart, liver, kidney, gastrointestinal tract diseases, nervous system, neural abnormities or metabolic abnormalities; No preparation allergies, serious infection or injury, etc.
- Medically healthy subjects with clinically normal laboratory profiles and ECGs.
- Subjects must agree to take effective contraceptive methods to prevent pregnancy from the start of screening until 3 months of last dose administration
Key exclusion criteria (12 listed)
- History of allergy or hypersensitivity to amlodipine
- Significant history of neurological, cardiovascular, digestive, respiratory, urinary, hematological, dysmetabolism or other diseases (such as psychosis) which is unfavorable to the study
- History of postural hypotension
- Blood donation or lost more than 400mL blood within 3 months prior to the study
- Use of medications within 2 weeks before 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 |
|---|---|---|
| LANDI-Amlodipine Besylate Tablet 5mgAlso: Amlodipine Tablet 5mgLANDI-Amlodipine Besylate Tablet 5mg is a generic product manufactured by YangTZE River Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd. | Drug | LANDI-Amlodipine Besylate Tablet 5mg |
| Norvasc Tablets 5mgAlso: Amlodipine Tablet 5mgNorvasc Tablet 5mg will be used as a comparator drug for the BE study. | Drug | Norvasc Tablets 5mg |
Primary outcome
Bioequivalence based on Peak Plasma Concentration (Cmax)
Time frame: 144 hours
1 secondary outcome
Bioequivalence based on Area under the plasma concentration versus time curves (AUC)
Time frame: 144 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 13 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Yanmei Liu principal investigator
Xuhui Central Hospital, Shanghai
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 LANDI-Amlodipine Besylate Tablet 5mg and Norvasc Tablets 5mg in people with Bioequivalence, run by Shanghai Haini Pharmaceutical Co., Ltd. at 1 site in China.
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 6 inclusion and 12 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 13 Oct 2017. 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 China. 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?
Bioequivalence based on Peak Plasma Concentration (Cmax) (time frame: 144 hours). 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 13 Oct 2017.