HealthyPhase 1NCT06180720
Bioequivalence Study of Entacapone,Levodopa and Carbidopa Tablets in the Postprandial State in Healthy Chinese Subjects
A Phase 1 study testing Test (T) Entacapone,Levodopa and Carbidopa Tablets (II) and Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II) in people with Healthy, run by The Affiliated Hospital of Qingdao University.
Trial summary
In this trial, 36 healthy subjects are planned to be enrolled in postprandial, and the postprandial trials will be randomized separately. According to the randomization table, subjects will be randomly assigned to one of the two groups (Group A: TRTR, Group B: RTRT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test (T) Entacapone,Levodopa and Carbidopa Tablets (II) and Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2023to 20 Nov 2024
- 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
- Voluntarily sign an informed consent form before the trial and fully understand the content, process and possible adverse effects of the trial.
- Ability to complete research in accordance with the requirements of the pilot program.
- The subject is willing to be free of pregnancy, sperm or egg donation and to voluntarily use effective contraception from the time of signing (female subject has used effective contraception for 14 days prior to the first dose of the drug) to 6 months after the last dose of the drug.
- Healthy male and female subjects aged 18 years or older (including 18 years of age).
- Male subjects weighed no less than 50.0 kg and female subjects weighed no less than 45.0 kg, with a body mass index in the range of 19.0 to 28.0 kg/m2 (including threshold values).
Who cannot join
- History of serious medical conditions such as cardiac, hepatic, renal, gastrointestinal, neurological, endocrine, respiratory, and psychiatric abnormalities, which are deemed inappropriate for the participant by the study physician#
- Abnormalities judged by the clinician to be clinically significant, including physical examination, vital signs examination, electrocardiogram, or clinical laboratory tests#
- Previous or existing postural hypotension or morning dizziness#
- Those with bile duct obstruction or a history of bile duct obstruction, or those with narrow-angle glaucoma, chronic open-angle glaucoma, ischemic heart disease, or myocardial infarction disease or history#
- Previous or existing suspicious and undiagnosed skin lesions or a history of melanoma#
- Those with a history of malignant nerve blocker syndrome (NMS) and/or non-traumatic rhabdomyolysis#
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- Persons with a history of specific allergies (asthma, etc.) or current allergic diseases (hives, eczema, etc.), or allergies (e.g., persons allergic to two or more medications, foods such as milk, or pollen), or known allergies to carbidopa, levodopa, entacapone, or any of the drug components#
- Those with dysphagia or any history of gastrointestinal disorders that interfere with drug absorption (e.g., gastric or small bowel resection, atrophic gastritis, peptic ulcer, gastrointestinal bleeding, obstruction, etc.)#
- Female subjects who are pregnant, breastfeeding, or have a positive pregnancy test result
- Those who are positive for any one or more of Hepatitis B Surface Antigen, Hepatitis C Antibody, HIV Antibody, or Syphilis Antibody#
- History of substance abuse within five years, or drug use within three months prior to screening, or positive urine drug screen#
- Those who consumed an average of more than 14 units of alcohol (1 unit = 360 milliliter of beer or 45 milliliter of spirits with 40% alcohol by volume or 150 milliliter of wine) per week in the 3 months prior to screening, or those who were unable to stop their alcohol intake from 24h prior to dosing until the end of the trial, or those who had a positive breath test for alcohol#
- Those who smoked an average of more than 5 cigarettes per day in the 3 months prior to screening or those who refused not to use tobacco products during their stay#
- History of surgical procedure within 3 months prior to screening or planned surgery during the study period#
- Those who have donated blood or lost a significant amount of blood (>400milliliter, except for physiologic blood loss in females) within 3 months prior to the first dose, or those who have donated ≥2 therapeutic doses of platelets within 1 month#
- Participation in a clinical trial of any drug and taking the drug within 3 months prior to the first dose#
- The use of nonselective monoamine oxidase inhibitors (e.g., phenelzine and antiphencyclidine), tricyclic antidepressants, dopamine D2 receptor antagonists (e.g., phenothiazines and risperidone), and isoniazid, phenytoin, and iron salts, metoclopramide, capnography interfering with bile duct excretion, chylomicrons, and small intestinal-glucuronidase (e.g., propoxur and erythromycin), in the 30 days prior to the first dose of the drug, rifampicin and chloramphenicol), pyridoxine, highly protein- bound drugs (e.g., warfarin, salicylic acid, prednisone, and disulfiram), CYP2C9 inhibitors (e.g., amiodarone, cimetidine, isoniazid), and CYP2C9 inducers (e.g., barbiturates, dexamethasone, ritonavir)#
- Those who received a live attenuated vaccine within 14 days prior to the first dose, or who received a live attenuated vaccine during a planned trial#
- Those who have taken any prescription medication within 14 days prior to the first dose#
- Those who have taken any over-the-counter medications, herbs, or supplements within 7 days prior to the first dose#
- Anyone who has taken a special diet (e.g., grapefruit and products containing grapefruit), or any food or beverage rich in caffeine or xanthines (e.g., coffee, tea, chocolate, cocoa, milk tea, etc.), or who has been subjected to strenuous physical activity, or any other factor that affects the absorption, distribution, metabolism, or excretion of the drug in the 48h prior to the first dose of the drug#
- Those who have difficulty collecting blood from a vein or have a history of needle and blood sickness#
- Those who have special dietary requirements or are unable to comply with the uniform rules of the clinical research center#
- Subjects who are unable to participate in the trial for their own reasons#
- Subjects judged by other investigators to be unsuitable for participation. -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Single-Center, Open, Randomized, Single-Dose, Completely Repeated Crossover Bioequivalence Study to Evaluate the Effects of the Test/Reference Preparation, Entacapone,Levodopa and Carbidopa Tablets (II) in the Postprandial State in Healthy Adult Subjects
In this trial, 36 healthy subjects are planned to be enrolled in postprandial, and the postprandial trials will be randomized separately. According to the randomization table, subjects will be randomly assigned to one of the two groups (Group A: TRTR, Group B: RTRT). The washout period (dosing interval) between doses will be at least 2 days. Taking the washout period of 2 days as an example, all subjects will take the corresponding medication according to the randomization table on day 1 of the first cycle trial, day 3 of the second cycle trial, day 5 of the third cycle trial, and day 7 of the fourth cycle trial.
- Conditions
- Healthy
- Being tested
- Test (T) Entacapone,Levodopa and Carbidopa Tablets (II), Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test (T) Entacapone,Levodopa and Carbidopa Tablets (II)Drug
Specification:Levodopa 100mg, Carbidopa 25mg, Entacapone 200mg(Abbreviation: 100mg/25mg/200mg). Produced and supplied by Qilu Pharmaceutical Co.
Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II)Drug
Specification:Levodopa 100mg, Carbidopa 25mg, Entacapone 200mg(Abbreviation: 100mg/25mg/200mg). Supplied by Qilu Pharmaceutical Co.
| Study group | Role | What they receive |
|---|---|---|
| Test (T)-Reference (R) | Experimental | In this trial, 36 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group A: Test (T)-Reference (R), The washout period (dosing interval) between doses will be at least 2 days. After fasting for at least 10 hours. Receives: Drug: Test (T) Entacapone,Levodopa and Carbidopa Tablets (II); Drug: Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II) |
| Reference (R)-Test (T) | Experimental | In this trial, 36 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group B: Reference (R)-Test (T), The washout period (dosing interval) between doses will be at least 2 days. After fasting for at least 10 hours. Receives: Drug: Test (T) Entacapone,Levodopa and Carbidopa Tablets (II); Drug: Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 10hours
Area under the plasma concentration versus time curve (AUC0-t)
Area under the drug concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t
Measured: 10hours
Area under the plasma concentration versus time curve (AUC0-∞)
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinite Time
Measured: 10hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start20 Dec 2023 (estimated)
- Primary completion4 Jan 2024 (estimated)
- Study completion20 Nov 2024 (estimated)
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.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cao Yu, The Affiliated Hospital of Qingdao University
- Investigators
- Yu Cao, Principal investigator, The Affiliated Hospital of Qingdao University Phase I Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180720
- Sponsor's protocol ID
- QLG1114-02
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center, Open, Randomized, Single-Dose, Completely Repeated Crossover Bioequivalence Study to Evaluate the Effects of the Test/Reference Preparation, Entacapone,Levodopa and Carbidopa Tablets (II) in the Postprandial State in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06180720
- Acronym / sponsor ID
- QLG1114-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 4 Jan 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 22 Dec 2023 (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.
In this trial, 36 healthy subjects are planned to be enrolled in postprandial, and the postprandial trials will be randomized separately. According to the randomization table, subjects will be randomly assigned to one of the two groups (Group A: TRTR, Group B: RTRT). The washout period (dosing interval) between doses will be at least 2 days. Taking the washout period of 2 days as an example, all subjects will take the corresponding medication according to the randomization table on day 1 of the first cycle trial, day 3 of the second cycle trial, day 5 of the third cycle trial, and day 7 of the fourth cycle trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test (T)-Reference (R) | Experimental | Drug: Test (T) Entacapone,Levodopa and Carbidopa Tablets (II), Drug: Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II)In this trial, 36 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group A: Test (T)-Reference (R), The washout period (dosing interval) between doses will be at least 2 days. After fasting for at least 10 hours. |
| Reference (R)-Test (T) | Experimental | Drug: Test (T) Entacapone,Levodopa and Carbidopa Tablets (II), Drug: Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II)In this trial, 36 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group B: Reference (R)-Test (T), The washout period (dosing interval) between doses will be at least 2 days. After fasting for at least 10 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily sign an informed consent form before the trial and fully understand the content, process and possible adverse effects of the trial.
- Ability to complete research in accordance with the requirements of the pilot program.
- The subject is willing to be free of pregnancy, sperm or egg donation and to voluntarily use effective contraception from the time of signing (female subject has used effective contraception for 14 days prior to the first dose of the drug) to 6 months after the last dose of the drug.
- Healthy male and female subjects aged 18 years or older (including 18 years of age).
- Male subjects weighed no less than 50.0 kg and female subjects weighed no less than 45.0 kg, with a body mass index in the range of 19.0 to 28.0 kg/m2 (including threshold values).
Key exclusion criteria (25 listed)
- History of serious medical conditions such as cardiac, hepatic, renal, gastrointestinal, neurological, endocrine, respiratory, and psychiatric abnormalities, which are deemed inappropriate for the participant by the study physician#
- Abnormalities judged by the clinician to be clinically significant, including physical examination, vital signs examination, electrocardiogram, or clinical laboratory tests#
- Previous or existing postural hypotension or morning dizziness#
- Those with bile duct obstruction or a history of bile duct obstruction, or those with narrow-angle glaucoma, chronic open-angle glaucoma, ischemic heart disease, or myocardial infarction disease or history#
- Previous or existing suspicious and undiagnosed skin lesions or a history of melanoma#
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 |
|---|---|---|
| Test (T) Entacapone,Levodopa and Carbidopa Tablets (II)Specification:Levodopa 100mg, Carbidopa 25mg, Entacapone 200mg(Abbreviation: 100mg/25mg/200mg). Produced and supplied by Qilu Pharmaceutical Co. | Drug | Reference (R)-Test (T), Test (T)-Reference (R) |
| Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II)Specification:Levodopa 100mg, Carbidopa 25mg, Entacapone 200mg(Abbreviation: 100mg/25mg/200mg). Supplied by Qilu Pharmaceutical Co. | Drug | Reference (R)-Test (T), Test (T)-Reference (R) |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 10hours
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC0-t)
Time frame: 10hours
Area under the drug concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t
Area under the plasma concentration versus time curve (AUC0-∞)
Time frame: 10hours
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinite Time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
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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.
Yu Cao principal investigator
The Affiliated Hospital of Qingdao University Phase I Clinical Research Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test (T) Entacapone,Levodopa and Carbidopa Tablets (II) and Reference (R) Entacapone,Levodopa and Carbidopa Tablets (II) in people with Healthy, run by The Affiliated Hospital of Qingdao University.
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 22 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Cao (18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 10hours). 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 22 Dec 2023.