HypertensionPhase 1NCT05667818
An Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets,China in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions
A Phase 1 study testing Amlodipine besylate tablets (trade name: Norfloxacin ®） in people with Hypertension, run by Overseas Pharmaceuticals, Ltd. at 1 site in China.
Trial summary
Amlodipine Besylate Controlled-release Tablets in Healthy Volunteers in a Randomized, Open, Two-cycle, Double-cross, Fasting State Comparative Pharmacokinetic Study. Major objective: Taking amlodipine besylate controlled-release tablets (specification: 5 mg) developed by Overseas Pharmaceuticals, Ltd. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Amlodipine besylate tablets (trade name: Norfloxacin ®）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 28 Jan 2023to 10 Mar 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects fully understand the purpose, nature, method and possible adverse reactions of the trial, voluntarily serve as subjects, and sign an informed consent form before any research procedure.
- Healthy subjects over the age of 18 (including the age of 18) can be both male and female.
- Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; Body mass index (BMI) is in the range of 19.0~26.0 kg/m2 (including the critical value).
- From the signing of the informed consent form to the end of the study, there was no birth plan and voluntary adoption of appropriate and effective contraceptive measures, and there was no sperm or egg donation plan.
- Subjects who can communicate well with researchers and understand and comply with the requirements of this study
Who cannot join
- Allergic constitution, or a history of food or drug allergy or other allergic diseases (asthma, urticaria, eczema dermatitis, etc.); Or allergic to any component of amlodipine besylate.
- Have a history of hypotension, or have a history of aortic stenosis or coronary artery occlusion.
- Those who have poor condition of blood vessel puncture, or can not tolerate vein puncture, or have a history of needle and blood sickness.
- There are cardiovascular, blood, liver, kidney, endocrine, respiratory, digestive, nervous, mental, immune, skin and metabolic disorders and other system diseases that researchers think are clinically significant, or there is a chronic or serious history of these diseases; Or there is a history of surgery that may affect drug absorption and metabolism.
- Those with abnormal physical examination, vital sign examination, 12 lead ECG and laboratory examination, and those with clinical significance judged by the research doctor.
- Human immunodeficiency virus (HIV) antibody, or hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV) antibody, or Treponema pallidum antibody (Anti TP) test results are positive.
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- Pregnant women, lactating women, or women of childbearing age have unprotected sexual behavior within 14 days before the planned administration, or the pregnancy test results are positive.
- Those vaccinated within 3 months before screening (except for COVID-19 vaccine), or those vaccinated with COVID-19 vaccine within 1 week before screening, or those who plan to vaccinate any vaccine during the trial or within 1 week after the end of the study;
- Or blood donation/blood loss ≥ 400 mL or blood transfusion or use of blood products within 3 months before screening, or blood donation (including blood components) planned during the test or within 3 months after the test.
- Previous medication:
- Those who have a history of drug abuse or are positive for drug screening and have used drugs 6 months before screening, including MDMA (ecstasy), methamphetamine (methamphetamine), ketamine, morphine, tetrahydrocannabinol acid (cannabis).
- Drugs that inhibit or induce liver metabolism of drugs (such as inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines, etc.) were used within 30 days before the first administration; Or 14 days before administration, any other drugs including prescription drugs, over-the-counter drugs, functional vitamins, health products or Chinese herbal medicine were used.
- Eating, smoking and drinking:
- People with dysphagia, or those who have special requirements for diet and cannot accept a unified diet.
- Those who used to drink too much caffeinated food or drink (such as coffee, strong tea, cola, chocolate, etc.) for a long time (more than 8 cups a day, 1 cup=250 mL), or take caffeinated food or drink within 72 hours before taking the drug for the first time, or can not be interrupted during the test.
- Food rich in purine (such as anchovies, sardine, cow liver, cow kidney, etc.), or grapefruit products are eaten within 48 hours before administration, or cannot be interrupted during the test.
- Those who have started significantly abnormal diet (such as diet and low sodium) within 4 weeks before screening.
- Excessive smoking within 6 months before screening (average ≥ 5 cigarettes/day) or smoking within 48 hours before the first drug administration, or unable to stop using any tobacco products during the test period.
- People who have a history of alcoholism or regularly drank alcohol within 6 months before screening, that is, people who drink more than 14 units of alcohol every week (1 unit=360 mL of beer with an alcohol content of 5%, 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine with an alcohol content of 12%), or people who drink or eat food or drink containing alcohol within 48 hours before taking drugs for the first time, or people who have positive alcohol breath test on the day of their first stay, or who cannot stop drinking alcohol during the study period.
- other:
- Those who have participated in or are participating in clinical trials of other drugs within 3 months before screening (defined as those who have used clinical research drugs).
- Subjects who are judged by the investigator to be unsuitable for other factors in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital of Southern Medical University
Guangdong, Guangzhou, 510280
Dr.shuai he, Doctor of pharmacy, +8618925092493, hs43555@163.com
About this study
Official title: An Open-label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Two Way Crossover, Single Oral Dose Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets, EQ 5mg Base of Overseas Pharmaceuticals Ltd., China and Norvasc®(Amlodipine Besylate) Tablets, 5mg of Pfizer Laboratories Div. Pfizer Inc., in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions
Amlodipine Besylate Controlled-release Tablets in Healthy Volunteers in a Randomized, Open, Two-cycle, Double-cross, Fasting State Comparative Pharmacokinetic Study.
Major objective:
Read more
Taking amlodipine besylate controlled-release tablets (specification: 5 mg) developed by Overseas Pharmaceuticals, Ltd. as the test preparation and amlodipine besylate tablets (trade name: Luohuoxi, specification: 5 mg) produced by Pfizer Inc. as the control preparation, the pharmacokinetics parameters of the single oral administration test preparation and the control preparation in China healthy volunteers were investigated and compared in an fasting state.
Secondary objective:
To evaluate the safety of single oral administration of test preparation and control preparation in China healthy volunteers on an empty stomach.
Read the detailed description
A single-center, randomized, open, two-cycle, double-cross, fasting experimental design method was adopted. All subjects must sign an informed consent form before taking part in the trial. Physical examination was conducted from the 14th day to the 1st day after administration, and the subjects the investigatorsre randomly assigned to one of the two sequential groups (T-R group and R-T group) according to the ratio of 1:1. That is, in the first cycle, 8 subjects in group T took one tablet of test preparation (amlodipine besylate controlled-release tablet, specification: 5mg) orally on an empty stomach; Group r: 8 subjects took one tablet of control preparation (amlodipine besylate tablet, Luohuoxi, specification: 5 mg) orally on an empty stomach, and about 240 ml of warm water was taken. Cross administration after 14 days.
On the morning of taking medicine, after the collection of blank blood samples, group T took one tablet of the test preparation (amlodipine besylate controlled-release tablets) orally; In group R, the oral control preparation (amlodipine besylate tablet) was taken with about 240 ml warm water. After 4 hours of administration, the standard meal was taken uniformly. Drinking water (except 240 ml water for medicinal purposes) is prohibited within 1 h before and 1 h after administration, and a unified diet is required during the experiment. The cleaning period was 14 days, and after 14 days, the drugs the investigatorsre administered in a cross way.
PK blood collection and blood sample treatment: 0 h before administration (within 1.0 h before administration) and 1.0 h, 2.0 h、3.0 h、3.5 h、4.0 h、4.5 h、5.0 h、5.5 h、6.0 h、6.5 h、7.0 h、7.5 h、8.0 h、8.5 h、9.0 h、10.0 h、12.0 h、14.0 h、16.0 h、24.0 h、36.0 h、48.0 h、72.0 h、96.0 h、144.0 h、168.0 h, a total of 27 time points to collect upper limb venous blood.
0 h before administration (within 1.0 h before administration) and 6.0± 0.5 h、12.0± 0.5 h、24.0±1.0 h、48.0±1.0 h、72.0±1.0 h、96.0±1.0 h、144.0±1.0 h、168.0±1.0 h after administration. The operating procedure of the second cycle is the same as that of the first cycle. In the second cycle, on the day after the sampling, the subjects need physical examination, vital signs examination, electrocardiogram and laboratory examination.
During the study, the investigators should observe and ask the subjective feelings of the subjects and the possible adverse reactions and events during the experiment. If the subject has AE during the trial, the researcher should try to follow up until the adverse events are relieved, or return to the screening level, or the subject's condition is stable.
- Conditions
- Hypertension
- Being tested
- Amlodipine besylate tablets (trade name: Norfloxacin ®）, Amlodipine besylate controlled-release tablets
- Keywords
- Hypertension, Healthy Volunteers, morning surge, Amlodipine Besylate
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine besylate tablets (trade name: Norfloxacin ®）Drug
Specification: 5 mg Batch No.: FX3445 Content: 100.2% Expiry date: January 2027 Storage conditions: dark and sealed Manufacturer: Pfizer Inc. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day.
Amlodipine besylate controlled-release tabletsDrug
Test preparation (T): amlodipine besylate controlled-release tablets Specification: 5 mg Batch No.: 22102501 Content: 100.9% Expiry date: October 24, 2024 Storage conditions: dark, sealed at room temperature. Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day.
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine besylate controlled-release tablets | Experimental | Test preparation (T): amlodipine besylate controlled-release tablets Specification: 5 mg Batch No.: 22102501 Content: 100.9% Expiry date: October 24, 2024 Storage conditions: dark, sealed at room temperature. Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day. Receives: Drug: Amlodipine besylate controlled-release tablets |
| Amlodipine besylate tablets (trade name: Norfloxacin ®） | Active comparator | Specification: 5 mg Batch No.: FX3445 Content: 100.2% Expiry date: January 2027 Storage conditions: dark and sealed Manufacturer: Pfizer Inc. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day. Receives: Drug: Amlodipine besylate tablets (trade name: Norfloxacin ®） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time zero to the time of the last quantifiable plasma
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-last within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Measured: 1 month
Area under the curve from time zero to infinity (AUC0-inf)
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of AUC0-inf within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Measured: 1 month
Peak concentration at each treatment period (Cmax,tp)
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of Cmax,tp within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Measured: 1 month
Secondary outcomes (4)
Peak concentration of the first dosing (Cmax)
Individual felodipine plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Time to reach peak concentration of the first dosing (Tmax)
Individual felodipine plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Terminal half-life (T1/2)
Individual felodipine plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Mean residence time (MRT)
Individual felodipine plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start28 Jan 2023 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion10 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Test preparation (T): amlodipine besylate controlled-release tablets Specification: 5 mg Batch No.: 22102501 Content: 100.9% Expiry date: October 24, 2024 Storage conditions: dark, sealed at room temperature. Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Overseas Pharmaceuticals, Ltd. Reference preparation (R): amlodipine besylate tablets (trade name: Norfloxacin ®） Specification: 5 mg Batch No.: FX3445 Content: 100.2% Expiry date: January 2027 Storage conditions: dark and sealed Manufacturer: Pfizer Inc. Provider: Overseas Pharmaceuticals, Ltd.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Health Start Pharmaceutical Techology Co.,Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667818
- Sponsor's protocol ID
- YYKQ-202210-2
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Two Way Crossover, Single Oral Dose Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets, EQ 5mg Base of Overseas Pharmaceuticals Ltd., China and Norvasc®(Amlodipine Besylate) Tablets, 5mg of Pfizer Laboratories Div. Pfizer Inc., in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05667818
- Acronym / sponsor ID
- YYKQ-202210-2
- Conditions
- Hypertension
- Keywords
- Hypertension, Healthy Volunteers, morning surge, Amlodipine Besylate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Health Start Pharmaceutical Techology Co.,Ltd
- Study start
- 28 Jan 2023 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 10 Mar 2023 (estimated)
- First posted
- 29 Dec 2022 (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.
Amlodipine Besylate Controlled-release Tablets in Healthy Volunteers in a Randomized, Open, Two-cycle, Double-cross, Fasting State Comparative Pharmacokinetic Study.
Major objective:
Taking amlodipine besylate controlled-release tablets (specification: 5 mg) developed by Overseas Pharmaceuticals, Ltd. as the test preparation and amlodipine besylate tablets (trade name: Luohuoxi, specification: 5 mg) produced by Pfizer Inc. as the control preparation, the pharmacokinetics parameters of the single oral administration test preparation and the control preparation in China healthy volunteers were investigated and compared in an fasting state.
Secondary objective:
To evaluate the safety of single oral administration of test preparation and control preparation in China healthy volunteers on an empty stomach.
Detailed description
A single-center, randomized, open, two-cycle, double-cross, fasting experimental design method was adopted. All subjects must sign an informed consent form before taking part in the trial. Physical examination was conducted from the 14th day to the 1st day after administration, and the subjects the investigatorsre randomly assigned to one of the two sequential groups (T-R group and R-T group) according to the ratio of 1:1. That is, in the first cycle, 8 subjects in group T took one tablet of test preparation (amlodipine besylate controlled-release tablet, specification: 5mg) orally on an empty stomach; Group r: 8 subjects took one tablet of control preparation (amlodipine besylate tablet, Luohuoxi, specification: 5 mg) orally on an empty stomach, and about 240 ml of warm water was taken. Cross administration after 14 days.
On the morning of taking medicine, after the collection of blank blood samples, group T took one tablet of the test preparation (amlodipine besylate controlled-release tablets) orally; In group R, the oral control preparation (amlodipine besylate tablet) was taken with about 240 ml warm water. After 4 hours of administration, the standard meal was taken uniformly. Drinking water (except 240 ml water for medicinal purposes) is prohibited within 1 h before and 1 h after administration, and a unified diet is required during the experiment. The cleaning period was 14 days, and after 14 days, the drugs the investigatorsre administered in a cross way.
PK blood collection and blood sample treatment: 0 h before administration (within 1.0 h before administration) and 1.0 h, 2.0 h、3.0 h、3.5 h、4.0 h、4.5 h、5.0 h、5.5 h、6.0 h、6.5 h、7.0 h、7.5 h、8.0 h、8.5 h、9.0 h、10.0 h、12.0 h、14.0 h、16.0 h、24.0 h、36.0 h、48.0 h、72.0 h、96.0 h、144.0 h、168.0 h, a total of 27 time points to collect upper limb venous blood.
0 h before administration (within 1.0 h before administration) and 6.0± 0.5 h、12.0± 0.5 h、24.0±1.0 h、48.0±1.0 h、72.0±1.0 h、96.0±1.0 h、144.0±1.0 h、168.0±1.0 h after administration. The operating procedure of the second cycle is the same as that of the first cycle. In the second cycle, on the day after the sampling, the subjects need physical examination, vital signs examination, electrocardiogram and laboratory examination.
During the study, the investigators should observe and ask the subjective feelings of the subjects and the possible adverse reactions and events during the experiment. If the subject has AE during the trial, the researcher should try to follow up until the adverse events are relieved, or return to the screening level, or the subject's condition is stable.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Test preparation (T): amlodipine besylate controlled-release tablets Specification: 5 mg Batch No.: 22102501 Content: 100.9% Expiry date: October 24, 2024 Storage conditions: dark, sealed at room temperature. Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Overseas Pharmaceuticals, Ltd. Reference preparation (R): amlodipine besylate tablets (trade name: Norfloxacin ®） Specification: 5 mg Batch No.: FX3445 Content: 100.2% Expiry date: January 2027 Storage conditions: dark and sealed Manufacturer: Pfizer Inc. Provider: Overseas Pharmaceuticals, Ltd.
| Arm | Type | Receives |
|---|---|---|
| Amlodipine besylate controlled-release tablets | Experimental | Drug: Amlodipine besylate controlled-release tabletsTest preparation (T): amlodipine besylate controlled-release tablets Specification: 5 mg Batch No.: 22102501 Content: 100.9% Expiry date: October 24, 2024 Storage conditions: dark, sealed at room temperature. Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day. |
| Amlodipine besylate tablets (trade name: Norfloxacin ®） | Active comparator | Drug: Amlodipine besylate tablets (trade name: Norfloxacin ®）Specification: 5 mg Batch No.: FX3445 Content: 100.2% Expiry date: January 2027 Storage conditions: dark and sealed Manufacturer: Pfizer Inc. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects fully understand the purpose, nature, method and possible adverse reactions of the trial, voluntarily serve as subjects, and sign an informed consent form before any research procedure.
- Healthy subjects over the age of 18 (including the age of 18) can be both male and female.
- Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; Body mass index (BMI) is in the range of 19.0~26.0 kg/m2 (including the critical value).
- From the signing of the informed consent form to the end of the study, there was no birth plan and voluntary adoption of appropriate and effective contraceptive measures, and there was no sperm or egg donation plan.
- Subjects who can communicate well with researchers and understand and comply with the requirements of this study
Key exclusion criteria (22 listed)
- Allergic constitution, or a history of food or drug allergy or other allergic diseases (asthma, urticaria, eczema dermatitis, etc.); Or allergic to any component of amlodipine besylate.
- Have a history of hypotension, or have a history of aortic stenosis or coronary artery occlusion.
- Those who have poor condition of blood vessel puncture, or can not tolerate vein puncture, or have a history of needle and blood sickness.
- There are cardiovascular, blood, liver, kidney, endocrine, respiratory, digestive, nervous, mental, immune, skin and metabolic disorders and other system diseases that researchers think are clinically significant, or there is a chronic or serious history of these diseases; Or there is a history of surgery that may affect drug absorption and metabolism.
- Those with abnormal physical examination, vital sign examination, 12 lead ECG and laboratory examination, and those with clinical significance judged by the research doctor.
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 |
|---|---|---|
| Amlodipine besylate tablets (trade name: Norfloxacin ®）Specification: 5 mg Batch No.: FX3445 Content: 100.2% Expiry date: January 2027 Storage conditions: dark and sealed Manufacturer: Pfizer Inc. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day. | Drug | Amlodipine besylate tablets (trade name: Norfloxacin ®） |
| Amlodipine besylate controlled-release tabletsTest preparation (T): amlodipine besylate controlled-release tablets Specification: 5 mg Batch No.: 22102501 Content: 100.9% Expiry date: October 24, 2024 Storage conditions: dark, sealed at room temperature. Manufacturer: Overseas Pharmaceuticals, Ltd. Provider: Overseas Pharmaceuticals, Ltd. Take one tablet once a day. | Drug | Amlodipine besylate controlled-release tablets |
Primary outcome
Area under the curve from time zero to the time of the last quantifiable plasma
Time frame: 1 month
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-last within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Area under the curve from time zero to infinity (AUC0-inf)
Time frame: 1 month
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of AUC0-inf within [0.8, 1.25] range will be used to determine the result of bioequivalence.
Peak concentration at each treatment period (Cmax,tp)
Time frame: 1 month
The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of Cmax,tp within [0.8, 1.25] range will be used to determine the result of bioequivalence.
4 secondary outcomes
Peak concentration of the first dosing (Cmax)
Time frame: 1 month
Time to reach peak concentration of the first dosing (Tmax)
Time frame: 1 month
Terminal half-life (T1/2)
Time frame: 1 month
Mean residence time (MRT)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- 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.
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 Amlodipine besylate tablets (trade name: Norfloxacin ®） in people with Hypertension, run by Overseas Pharmaceuticals, 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 5 inclusion and 22 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 4 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Huaihan Cai, Director of Medical Affairs (+8618352616957, caihuaihan@overseaspharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve from time zero to the time of the last quantifiable plasma (time frame: 1 month). The study lists 3 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 4 Jan 2023.