HypertensionPhase 1NCT05614037
Felodipine Controlled Release Tablets and Felodipine Sustained Release Tablets in Healthy Subjects Under Fasting State Comparative Pharmacokinetic Study
A Phase 1 study testing Felodipine sustained release tablets (trade name: plendil®) in people with Hypertension, run by Overseas Pharmaceuticals, Ltd. at 1 site in China.
Trial summary
Felodipine Controlled Release Tablets and Felodipine Modified-release Tablets in Healthy Subjects Under Fasting State: Single Dose, Randomized, Open, 2-treatment，2-period，Crossover Comparative Pharmacokinetic Study Main research objectives: Felodipine Controlled Release Tablets(strength: 5 mg) developed by Overseas… 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?
- Felodipine sustained release tablets (trade name: plendil®)
- 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 Oct 2022to 30 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
- The subject is fully aware of the purpose, nature, method and possible adverse reactions of the study, voluntarily acts as a subject, and signs informed consent prior to the commencement of any study procedure.
- Healthy subjects (male or female) aged 18 years or older.
- Male weight ≥50.0 kg, female weight ≥45.0 kg; Body mass index (BMI) was in the range of 19.0 to 26.0 kg/m2 (including the critical value).
- From the signing of informed consent to 6 months after the end of the study, they had no fertility plan, voluntarily took appropriate and effective contraceptive measures, and had no sperm and egg donation plan.
- The subjects were able to communicate well with the researchers and understood and complied with the requirements of the study.
Who cannot join
- Allergic disposition or a history of food or drug allergy or other allergic diseases (asthma, urticaria, eczema dermatitis, etc.) that researchers deem clinically significant; Or allergic to any component of felodipine.
- Patients with poor vascular puncture conditions, or who cannot tolerate venipunction, or who have a history of fainting needles and fainting blood.
- Patients with gingivitis and periodontitis.
- Previous history of compensatory heart failure, acute myocardial infarction, unstable angina pectoris.
- lactose intolerance, or galactose intolerance, lactase deficiency, glucose-galactose malabsorption.
- Patients with confirmed hypotension or history of postural hypotension.
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- The presence of cardiovascular, blood, liver, kidney, endocrine, respiratory, digestive, nervous, psychiatric, immune, skin, metabolic disorders and other systemic diseases considered clinically significant by researchers, or a chronic or severe history of these diseases; Or a history of surgery that may affect drug absorption and metabolism.
- Physical examination, vital signs examination, 12-lead electrocardiogram and laboratory examination were abnormal and clinically significant as judged by the study physician.
- Positive for human immunodeficiency virus (HIV) antibody, hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or treponema pallidum antibody (Anti-TP).
- Pregnant women, breastfeeding women, or women of childbearing age who have unprotected sex or pregnancy test positive within 14 days before the planned dose.
- Those who received vaccines (other than COVID-19 vaccine) within 3 months prior to screening, or who received COVID-19 vaccine within 1 week prior to screening, or who plan to receive any vaccines during the trial or within 1 week after the study ends;
- Those who have donated blood/lost blood ≥400 mL in the 3 months prior to screening or who have received blood transfusions or used blood products, or who intend to donate blood (including blood components) during or 3 months after the end of the trial.
- Previous drug use:
- Those with a history of drug abuse or who have tested positive for drugs and used drugs in the six months prior to screening, including methylenedioxymethamphetamine (ecstasy), methamphetamine (meth), ketamine, morphine, and THC (marijuana).
- Drugs that inhibit or induce liver metabolism of drugs (such as inducers: barbiturates, carbamazepine, phenytoin, rifampicin, St. John's wort, etc.) were used within 28 days before the initial administration; Inhibitors: cimetidine, cyclosporine, pyrrole antifungal drugs (itraconazole, ketoconazole), macrolides antibiotics (erythromycin), HIV protease inhibitors, etc.); Or any other medication including prescription drugs, over-the-counter drugs, functional vitamins, health products, or Chinese herbs used in the 14 days prior to administration.
- Diet and smoking and alcohol consumption:
- People who have difficulty swallowing or have special requirements for diet and cannot accept unified diet.
- Habitual long-term consumption of excessive (more than 8 cups a day, 1 cup =250 mL) of food or drink containing caffeine (such as coffee, strong tea, cola, chocolate, etc.), or ingestion of food or drink containing caffeine within 72 hours before the first medication, or can not be interrupted during the trial.
- People who consumed purine-rich foods (such as anchovies, sardines, beef liver, beef kidney, etc.) or products containing grapefruit, grapefruit juice, grape juice, menthol within 48 hours before administration, or planned intake or could not be interrupted during the trial.
- Those who had started a significantly abnormal diet (e.g., diet, low sodium) within 4 weeks prior to screening.
- Excessive smoking within 6 months prior to screening (mean ≥5 doses/day) or within 48 hours prior to the first dose, or unable to stop using any tobacco products during the trial.
- those who have a history of alcoholism or are regular drinkers in the six months prior to screening, that is, drinking more than 14 units of alcohol per week (1 unit =360 mL beer with 5% alcohol by volume or 45 mL spirits with 40% alcohol by volume or 150 mL wine with 12% alcohol by volume), Or consumed alcohol or food or beverages within 48 hours before the first dose, or tested positive for alcohol on the day of the first cycle check-in, or were unable to stop alcohol consumption during the study period.
- Other:
- Participants who had participated or were participating in clinical trials of other drugs (defined as having used investigational drugs) in the 3 months prior to screening.
- Subjects who were assessed by the investigator for other factors unsuitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Clinical Trial Centre of Dongguan Kanghua Hospital
Dongguan, Guangdong, 523000
About this study
Official title: Felodipine Controlled Release Tablets and Felodipine Sustained Release Tablets in Healthy Subjects Under Fasting State: Single Dose, Randomized, Open, 2-treatment，2-period，Crossover Comparative Pharmacokinetic Study
Felodipine Controlled Release Tablets and Felodipine Modified-release Tablets in Healthy Subjects Under Fasting State: Single Dose, Randomized, Open, 2-treatment，2-period，Crossover Comparative Pharmacokinetic Study
Main research objectives:
Read more
Felodipine Controlled Release Tablets(strength: 5 mg) developed by Overseas Pharmaceuticals, Ltd., and Felodipine Modified-release Tablets (strength: 5 mg) produced by AstraZeneca AB., trade name: The pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects under fasting state were investigated and compared.
Secondary research objectives:
To observe the safety of test preparation and reference preparation in healthy subjects.
Read the detailed description
The subjects were randomly assigned in a 1:1 ratio to one of two sequential administration groups (group T-R, group R-T). In the first cycle, 8 subjects took the test formulation (T) 5 mg/tablet by fasting, and the other 8 subjects took the reference formulation (R) 5 mg/tablet by fasting, with about 240 mL warm water. The drug was crossed over after 14 days. Phase I trial site pharmacists assigned study drugs to each phase according to the randomization list.
Sixteen healthy subjects were randomly divided into two groups, T-R group and R-T group, with 8 cases in each group. The enrolled subjects entered the phase I observation room one day before the administration of each cycle, and were required to fast for more than 10 hours from the day before to the morning of the administration. After a blank blood sample was collected on the morning of administration, the study drug was administered in the fasting state. The standard meal was taken 4 hours after administration. Each week was performed at 0 h before administration (within 1.5 h before administration) and 0.5 h, 1.0 h, 1.5 h, 2.0 h, 2.5 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, 24.0 h, 48.0 h, 72.0 h, a total of 24 blood sampling points were collected from the upper limb vein.
Vital signs (including body temperature (frontal temperature), pulse and blood pressure) were measured at 0 h before administration (within 1.5 h before administration) and 4.0± 0.5 h, 8.0± 0.5 h, 24.0± 1.0 h, 48.0± 1.0 h and 72.0± 1.0 h after administration. The operation procedure of the second cycle is the same as that of the first cycle. In the second cycle, the subjects were required to take physical examination, vital signs examination, electrocardiogram and laboratory examination on the day after the end of sampling.
If a subject has an AE during the trial, the investigator should try to follow the subject until the adverse event resolves, or returns to the screening level, or the subject's condition is stable.
- Conditions
- Hypertension
- Being tested
- Felodipine sustained release tablets (trade name: plendil®), Felodipine Controlled Release Tablets
- Keywords
- Felodipine, Hypertension, Healthy Volunteers, morning surge
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Felodipine sustained release tablets (trade name: plendil®)Drug
Reference preparation (R) : Felodipine sustained release tablets (trade name: plendil ®) Specification: 5 mg Batch number: 2204 a11 Content: 99.1% Valid until March 2025 Storage conditions: below 25℃ Manufacturer: AstraZeneca AB Supplier: Overseas Pharmaceuticals, Ltd. Usage: Oral, 1 tablet at a time, once a day. Take it before bed and swallow it with water. Do not break, press or chew the pill.
Felodipine Controlled Release TabletsDrug
Test preparation (T) :Felodipine Controlled Release Tablets Specification: 5 mg Batch number: 22090301 Content: 100.8% Valid until: September 2024 Storage conditions: sealed, room temperature (10~30℃) Manufacturer: Overseas Pharmaceuticals, Ltd. Supplier: Overseas Pharmaceuticals, Ltd. Usage: Oral, 1 tablet at a time, once a day. Take it before bed and swallow it with water. Do not break, press or chew the pill.
| Study group | Role | What they receive |
|---|---|---|
| Felodipine Controlled Release Tablets | Experimental | Test preparation (T) :Felodipine Controlled Release Tablets Specification: 5 mg Batch number: 22090301 Content: 100.8% Valid until: September 2024 Storage conditions: sealed, room temperature (10~30℃) Manufacturer: Overseas Pharmaceuticals, Ltd. Supplier: Overseas Pharmaceuticals, Ltd. Usage: Oral, 1 tablet at a time, once a day. Take it before bed and swallow it with water. Do not break, press or chew the pill. Receives: Drug: Felodipine sustained release tablets (trade name: plendil®) |
| Felodipine Modified-release Tablets (trade name:plendil ®) | Active comparator | Reference preparation (R) : Felodipine Modified-release Tablets (trade name:plendil ®) Specification: 5 mg Batch number: 2204 a11 Content: 99.1% Valid until March 2025 Storage conditions: below 25℃ Manufacturer:AstraZeneca AB Supplier: Overseas Pharmaceuticals, Ltd. Usage: Oral, 1 tablet at a time, once a day. Take it before bed and swallow it with water. Do not break, press or chew the pill. Receives: Drug: Felodipine Controlled Release Tablets |
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 concentration of the period (AUC0-last)
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 posted14 Nov 2022
- Study start28 Oct 2022
- Primary completion20 Nov 2022
- Study completion30 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) : Felodipine Controlled Release Tablets Specification: 5 mg Batch number: 22090301 Content: 100.8% Valid until: September 2024 Storage conditions: sealed, room temperature (10\~30℃) Manufacturer: Overseas Pharmaceuticals, Ltd. Supplier: Overseas Pharmaceuticals, Ltd. Reference preparation (R) :Felodipine Modified-release tablets(trade name: plendil ®) Specification: 5 mg Batch number: 2204 a11 Content: 99.1% Valid until March 2025 Storage conditions: below 25℃ Manufacturer: AstraZeneca AB Supplier: Overseas Pharmaceuticals, Ltd.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Kangqi Medical Technology Co., LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614037
- Sponsor's protocol ID
- YYKQ-202207
- Status last verified
- Oct 2022
- First submitted
- 4 Nov 2022
- Last updated
- 1 Feb 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Felodipine Controlled Release Tablets and Felodipine Sustained Release Tablets in Healthy Subjects Under Fasting State: Single Dose, Randomized, Open, 2-treatment，2-period，Crossover Comparative Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT05614037
- Acronym / sponsor ID
- YYKQ-202207
- Conditions
- Hypertension
- Keywords
- Felodipine, Hypertension, Healthy Volunteers, morning surge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Kangqi Medical Technology Co., LTD
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 14 Nov 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.
Felodipine Controlled Release Tablets and Felodipine Modified-release Tablets in Healthy Subjects Under Fasting State: Single Dose, Randomized, Open, 2-treatment，2-period，Crossover Comparative Pharmacokinetic Study
Main research objectives:
Felodipine Controlled Release Tablets(strength: 5 mg) developed by Overseas Pharmaceuticals, Ltd., and Felodipine Modified-release Tablets (strength: 5 mg) produced by AstraZeneca AB., trade name: The pharmacokinetic parameters of the test preparation and the reference preparation in healthy subjects under fasting state were investigated and compared.
Secondary research objectives:
To observe the safety of test preparation and reference preparation in healthy subjects.
Detailed description
The subjects were randomly assigned in a 1:1 ratio to one of two sequential administration groups (group T-R, group R-T). In the first cycle, 8 subjects took the test formulation (T) 5 mg/tablet by fasting, and the other 8 subjects took the reference formulation (R) 5 mg/tablet by fasting, with about 240 mL warm water. The drug was crossed over after 14 days. Phase I trial site pharmacists assigned study drugs to each phase according to the randomization list.
Sixteen healthy subjects were randomly divided into two groups, T-R group and R-T group, with 8 cases in each group. The enrolled subjects entered the phase I observation room one day before the administration of each cycle, and were required to fast for more than 10 hours from the day before to the morning of the administration. After a blank blood sample was collected on the morning of administration, the study drug was administered in the fasting state. The standard meal was taken 4 hours after administration. Each week was performed at 0 h before administration (within 1.5 h before administration) and 0.5 h, 1.0 h, 1.5 h, 2.0 h, 2.5 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, 24.0 h, 48.0 h, 72.0 h, a total of 24 blood sampling points were collected from the upper limb vein.
Vital signs (including body temperature (frontal temperature), pulse and blood pressure) were measured at 0 h before administration (within 1.5 h before administration) and 4.0± 0.5 h, 8.0± 0.5 h, 24.0± 1.0 h, 48.0± 1.0 h and 72.0± 1.0 h after administration. The operation procedure of the second cycle is the same as that of the first cycle. In the second cycle, the subjects were required to take physical examination, vital signs examination, electrocardiogram and laboratory examination on the day after the end of sampling.
If a subject has an AE during the trial, the investigator should try to follow the subject until the adverse event resolves, or returns 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) : Felodipine Controlled Release Tablets Specification: 5 mg Batch number: 22090301 Content: 100.8% Valid until: September 2024 Storage conditions: sealed, room temperature (10~30℃) Manufacturer: Overseas Pharmaceuticals, Ltd. Supplier: Overseas Pharmaceuticals, Ltd. Reference preparation (R) :Felodipine Modified-release tablets(trade name: plendil ®) Specification: 5 mg Batch number: 2204 a11 Content: 99.1% Valid until March 2025 Storage conditions: below 25℃ Manufacturer: AstraZeneca AB Supplier: Overseas Pharmaceuticals, Ltd.
| Arm | Type | Receives |
|---|---|---|
| Felodipine Controlled Release Tablets | Experimental | Drug: Felodipine sustained release tablets (trade name: plendil®)Test preparation (T) :Felodipine Controlled Release Tablets Specification: 5 mg Batch number: 22090301 Content: 100.8% Valid until: September 2024 Storage conditions: sealed, room temperature (10~30℃) Manufacturer: Overseas Pharmaceuticals, Ltd. Supplier: Overseas Pharmaceuticals, Ltd. Usage: Oral, 1 tablet at a time, once a day. Take it before bed and swallow it with water. Do not break, press or chew the pill. |
| Felodipine Modified-release Tablets (trade name:plendil ®) | Active comparator | Drug: Felodipine Controlled Release TabletsReference preparation (R) : Felodipine Modified-release Tablets (trade name:plendil ®) Specification: 5 mg Batch number: 2204 a11 Content: 99.1% Valid until March 2025 Storage conditions: below 25℃ Manufacturer:AstraZeneca AB Supplier: Overseas Pharmaceuticals, Ltd. Usage: Oral, 1 tablet at a time, once a day. Take it before bed and swallow it with water. Do not break, press or chew the pill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject is fully aware of the purpose, nature, method and possible adverse reactions of the study, voluntarily acts as a subject, and signs informed consent prior to the commencement of any study procedure.
- Healthy subjects (male or female) aged 18 years or older.
- Male weight ≥50.0 kg, female weight ≥45.0 kg; Body mass index (BMI) was in the range of 19.0 to 26.0 kg/m2 (including the critical value).
- From the signing of informed consent to 6 months after the end of the study, they had no fertility plan, voluntarily took appropriate and effective contraceptive measures, and had no sperm and egg donation plan.
- The subjects were able to communicate well with the researchers and understood and complied with the requirements of the study.
Key exclusion criteria (25 listed)
- Allergic disposition or a history of food or drug allergy or other allergic diseases (asthma, urticaria, eczema dermatitis, etc.) that researchers deem clinically significant; Or allergic to any component of felodipine.
- Patients with poor vascular puncture conditions, or who cannot tolerate venipunction, or who have a history of fainting needles and fainting blood.
- Patients with gingivitis and periodontitis.
- Previous history of compensatory heart failure, acute myocardial infarction, unstable angina pectoris.
- lactose intolerance, or galactose intolerance, lactase deficiency, glucose-galactose malabsorption.
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 |
|---|---|---|
| Felodipine sustained release tablets (trade name: plendil®)Reference preparation (R) : Felodipine sustained release tablets (trade name: plendil ®) Specification: 5 mg Batch number: 2204 a11 Content: 99.1% Valid until March 2025 Storage conditions: below 25℃ Manufacturer: AstraZeneca AB Supplier: Overseas Pharmaceuticals, Ltd. Usage: Oral, 1 tablet at a time, once a day. Take it before bed and swallow it with water. Do not break, press or chew the pill. | Drug | Felodipine Controlled Release Tablets |
| Felodipine Controlled Release TabletsTest preparation (T) :Felodipine Controlled Release Tablets Specification: 5 mg Batch number: 22090301 Content: 100.8% Valid until: September 2024 Storage conditions: sealed, room temperature (10~30℃) Manufacturer: Overseas Pharmaceuticals, Ltd. Supplier: Overseas Pharmaceuticals, Ltd. Usage: Oral, 1 tablet at a time, once a day. Take it before bed and swallow it with water. Do not break, press or chew the pill. | Drug | Felodipine Modified-release Tablets (trade name:plendil ®) |
Primary outcome
Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last)
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 1 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Felodipine sustained release tablets (trade name: plendil®) 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 25 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 1 Feb 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?
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?
Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last) (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 1 Feb 2023.