Chronic Insomnia CharacterizedPhase 1NCT06890715
Comparative Pharmacokinetic Study of Ramelteon Modified-Release Tablets and Ramelteon Tablets in Healthy Subjects
A Phase 1 study testing Test product (T): Ramelteon Modified-Release Tablets and Reference product (R): Ramelteon Tablets in people with Chronic Insomnia Characterized, run by Overseas Pharmaceuticals, Ltd. at 1 site in China.
Trial summary
A randomized, open-label, two-period, double-crossover comparative pharmacokinetic (PK) study of a single oral dose of Ramelteon Modified-Release Tablets and Ramelteon Tablets in Chinese healthy subjects Primary objective: To evaluate the bioequivalence of the test product and the reference product by comparing their… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Insomnia Characterized
- What is being tested?
- Test product (T): Ramelteon Modified-Release Tablets and Reference product (R): Ramelteon Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2024to 8 Jul 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects aged 18 to 45 years (including 18 and 45 years);
- Male subjects with a body weight ≥ 50.0 kg, and female subjects with a body weight ≥ 45.0 kg; BMI (BMI = body weight (kg)/[height (m)]2) within the range of 19-26.0 kg/m2 (including the critical value);
- Subject who fully understands 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;;
- Subjects who are able to communicate well with the investigator and understand and adhere to the study requirements.
Who cannot join
- Subjects with an allergic history to the study drug or other melatonin or any other component of the study drug, or an allergic history to drug, food , pollen or a specific allergic history (asthma, allergic rhinitis);
- Subjects who have special dietary requirements and cannot accept a unified diet;
- Subjects with a history of dysphagia or any gastrointestinal disorder affecting drug absorption;
- Subjects who cannot tolerate venipuncture , or with needle fainting or blood collection difficulties;
- Subjects with clinically significant hematological, endocrine, cardiovascular, hepatic, renal and pulmonary disorders that may affect drug absorption, distribution, metabolism and excretion;
- Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, coagulation four, pregnancy test (female), etc.), 12-lead electrocardiogram, chest X-ray examination results judged by researchers to be clinically significant;
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- Subjects with a surgical history within the 3 months prior to the study or taking the study drug or who plan to have surgery during the trial ；
- Those who received the vaccine within 28 days before the first dose； 9) Subjects with blood donation or massive blood loss (> 450 mL) within 3 months before the study;
- 10) Subjects taking special diet (including pitaya or grapefruit and products containing grapefruit ingredients) or having strenuous exercise within 7 days before taking the study drug, or having other factors affecting drug absorption, distribution, metabolism and excretion; 11) Subjects administered with any prescription drugs, over-the-counter, herbal, or health products within 14 days prior to taking the study drug; 12) Drug users with a history of interaction with rametylamine tablets within 30 days prior to screening (fluvoxamine, rifampicin, ketoconazole, fluconazole, Donepezil, doxepin, Zolpidem, etc.; 13) Regular drinkers within 6 months prior to the study, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirit containing 40% alcohol or 150 mL of wine); 14) Subjects who have a history of smoking in the first 3 months of prior to screening; Or who cannot stop using any tobacco products during the test period; Or positive results of tobacco test; 15) Subjects who have consumed chocolate, any caffeine-containing, or xanthine-rich food or beverage, such as coffee, strong tea, and cola 48 h before taking the study drug; 16) Subjects having taken any alcohol-containing products within 48 h before taking the study drug, or having a positive result for alcohol screening; Subjects positive for drug screening or with a history of drug abuse within the past five years or using drugs 3 months before the trial; 17) Female subjects with positive pregnancy test or lactating during the screening period or during the trial;Subjects (including male subjects) had a birth plan or could not use effective contraception from 2 weeks before the trial screening to 1 month after the trial ended; 18) Subjects positive for HBsAg, HCV-Ab, anti-HIV or primary syphilis screening; 19) Subjects who have participated in other clinical trials and used experimental drugs or devices within 3 months prior to screening; 20) Subjects with underlying medical, psychiatric, psychological or other discomfort conditions, poor compliance, or who, as judged by the investigator, are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
clinical trial centre of Medical ethics committee of Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510700
About this study
Official title: A Randomized, Open-label, Two-period, Double-crossover Comparative Pharmacokinetic (PK) Study of a Single Oral Dose of Ramelteon Modified-Release Tablets and Ramelteon Tablets in Chinese Healthy Subjects
A randomized, open-label, two-period, double-crossover comparative pharmacokinetic (PK) study of a single oral dose of Ramelteon Modified-Release Tablets and Ramelteon Tablets in Chinese healthy subjects Primary objective: To evaluate the bioequivalence of the test product and the reference product by comparing their plasma concentrations and main PK parameters by oral administration in healthy Chinese subjects using Ramelteon Modified-Release Tablets (strength: 8 mg/tablet) developed by Overseas Pharmaceuticals, Ltd. as the test product and Ramelteon Tablets (trade name: Rozerem®, strength: 8 mg/tablet) produced by Takeda Pharmaceuticals America, Inc. as the reference product. Secondary objective: To evaluate the safety of Ramelteon Modified-Release Tablets (test product) and Ramelteon Tablets (reference product) with oral administration after drinking milk in healthy Chinese subjects.
Read the detailed description
The trial was divided into screening period, period I, period II and safety follow-up period. The washout period is 2 days during the period.
Screening period: All subjects must sign an informed consent prior to participating in the trial. Screening tests were performed from Day -14 to Day 1 of administration.
Period I: 12 qualified subjects were screened and admitted to the Phase I ward of the Clinical Research Center on Day-1. After being reviewed and confirmed by the investigators, they were randomly divided into 2 groups, T-R group and R-T group, with 6 participants in each group. The normal diet was set at 8:00, 12:00 and 18:00 on the day of administration, and the uniform diet was required during the trial. After dinner at 18:00, all subjects were given 120mL whole milk starting at 21:57, one test product (Ramelteon Modified-Release Tablets (strength: 8 mg/tablet) or one reference product (Ramelteon Tablets (trade name: Rozerem®, strength: 8 mg/tablet) , and 120mL of warm water, the subject can lie down half after taking the drug, had no water within 1 hour after taking the drug, and fasted until breakfast the next day. PK blood samples were collected according to the time required by the scheme.
Period II : With a washout period of 2 days, the subjects underwent the period II of administration and blood collection on the night of Day 3, and the trial method in period II is the same as that in period I.
Vital signs (including body temperature, respiration, pulse, and blood pressure) were measured 1 hour before administration, at 2.0±0.5h, 5.0±0.5h, and 24.0±1.0h after each period of administration. Subjects were hospitalized throughout the trial period and underwent physical examination, vital signs measurement, electrocardiogram, and laboratory-related tests on Day 3 after the period II of dosing (female subjects were required to undergo blood pregnancy tests). Subject Lelt the stage I ward after completing PK sampling and the above examination.
Safety Follow-up: During the Day 8-Day 11 period, subjects will be contacted by telephone to collect information on drug combinations and adverse events after discharge from the study center.
Blood sample collection and processing: Cubital venous blood will be collected at 29 time points: before administration (0 h) (within 1.0h before administration) and 20min, 40min, 1h, 1h20min, 1h40min, 2h, 2h20min, 2h40min, 3h, 3h20min, 3h40min, 4h, 4h20min, 4h40min, 5h, 5h20min, 5h40min, 6h, 6h20min, 6h40min, 7h, 7h20min, 7h40min, 8h, 9h, 10h, 12h and 24h after administration of each period, and 4.0mL of blood was drawn and placed in the labeled EDTA-2K anticoagulant vacuum blood collection tube. Immediately after blood collection, the sampling vessels were gently and completely reversed three times and mixed with anticoagulant and temporarily placed at room temperature until centrifugation, centrifuged at 4℃ (set at 2-8 ℃) at 1700g for 10min. After centrifugation, the samples were removed from the centrifuge, and the plasma was collected and divided into two tubes (detection tube and backup tube) with corresponding labels. The test tube is about 0.8mL, and the remaining plasma is loaded into the backup tube. Blood samples were collected from the beginning, centrifugation was completed within 60 minutes, and plasma was frozen at -20 ° C (-30 ° C ~-10 ° C) or -80 ° C (-90 ° C ~-60 ° C) within 120 minutes. Samples stored in the -20 ° C refrigerator were transferred to the -80 ° C refrigerator for storage after 24 hours of blood collection. After the collection of blood samples of all subjects, the plasma samples of the detection tube will be transferred to the analysis and testing center for blood concentration determination, and the plasma samples of the backup tube will be stored in the clinical research unit or a third party designated by the sponsor.
- Conditions
- Chronic Insomnia Characterized
- Being tested
- Test product (T): Ramelteon Modified-Release Tablets, Reference product (R): Ramelteon Tablets
- Keywords
- Ramelteon, Modified-Release, Chronic insomnia characterized by difficulties in falling asleep or maintaining sleep, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test product (T): Ramelteon Modified-Release TabletsDrug
Oral, take 1 tablet at a time, once a day.
Reference product (R): Ramelteon TabletsDrug
Oral, take 1 tablet at a time, once a day.
| Study group | Role | What they receive |
|---|---|---|
| Group T | Experimental | Test product (T): Ramelteon Modified-Release Tablets Strength: 8 mg/tablet Batch No.: G12308010 Content: 8 mg/tablet Valid to: 2025-8-16 Storage Conditions:Not higher than 25°C, sealed store Manufacturer: Overseas Pharmaceuticals, Ltd. Receives: Drug: Test product (T): Ramelteon Modified-Release Tablets |
| Group R | Active comparator | Reference product (R): Ramelteon Tablets Strength: 8 mg/tablet Batch No.: 12216533 Content: 8 mg/tablet Valid to: 2024-10 Storage Conditions: 25 ° C (77°F) storage, allowing short-term temperature deviations of 15-30 ° C (59-86°F) Manufacturer:Takeda Pharmaceuticals America, Inc. Receives: Drug: Reference product (R): Ramelteon 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
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
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
Secondary outcomes (3)
Peak concentration of the first dosing (Cmax)
Individual ramelteon and ramelteon metabolite M-II 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 ramelteon and ramelteon metabolite M-II plasma concentration-time profile for each treatment period will be established.
Measured: 1 month
Terminal half-life (T1/2)
Individual ramelteon and ramelteon metabolite M-II 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 posted24 Mar 2025
- Study start24 Jun 2024
- Primary completion2 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Insomnia CharacterizedStudies 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
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing CTSmed Co. Ltd
- Responsible party
- Sponsor
- Investigators
- Shuai He Associate Chief Pharmacist, Doctor, Principal investigator, The Zhujiang Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890715
- Sponsor's protocol ID
- CTS-CO-2545
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 24 Mar 2025
- 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Two-period, Double-crossover Comparative Pharmacokinetic (PK) Study of a Single Oral Dose of Ramelteon Modified-Release Tablets and Ramelteon Tablets in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT06890715
- Acronym / sponsor ID
- CTS-CO-2545
- Conditions
- Chronic Insomnia Characterized
- Keywords
- Ramelteon, Modified-Release, Chronic insomnia characterized by difficulties in falling asleep or maintaining sleep, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Overseas Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing CTSmed Co. Ltd
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 24 Mar 2025 (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.
A randomized, open-label, two-period, double-crossover comparative pharmacokinetic (PK) study of a single oral dose of Ramelteon Modified-Release Tablets and Ramelteon Tablets in Chinese healthy subjects Primary objective: To evaluate the bioequivalence of the test product and the reference product by comparing their plasma concentrations and main PK parameters by oral administration in healthy Chinese subjects using Ramelteon Modified-Release Tablets (strength: 8 mg/tablet) developed by Overseas Pharmaceuticals, Ltd. as the test product and Ramelteon Tablets (trade name: Rozerem®, strength: 8 mg/tablet) produced by Takeda Pharmaceuticals America, Inc. as the reference product. Secondary objective: To evaluate the safety of Ramelteon Modified-Release Tablets (test product) and Ramelteon Tablets (reference product) with oral administration after drinking milk in healthy Chinese subjects.
Detailed description
The trial was divided into screening period, period I, period II and safety follow-up period. The washout period is 2 days during the period.
Screening period: All subjects must sign an informed consent prior to participating in the trial. Screening tests were performed from Day -14 to Day 1 of administration.
Period I: 12 qualified subjects were screened and admitted to the Phase I ward of the Clinical Research Center on Day-1. After being reviewed and confirmed by the investigators, they were randomly divided into 2 groups, T-R group and R-T group, with 6 participants in each group. The normal diet was set at 8:00, 12:00 and 18:00 on the day of administration, and the uniform diet was required during the trial. After dinner at 18:00, all subjects were given 120mL whole milk starting at 21:57, one test product (Ramelteon Modified-Release Tablets (strength: 8 mg/tablet) or one reference product (Ramelteon Tablets (trade name: Rozerem®, strength: 8 mg/tablet) , and 120mL of warm water, the subject can lie down half after taking the drug, had no water within 1 hour after taking the drug, and fasted until breakfast the next day. PK blood samples were collected according to the time required by the scheme.
Period II : With a washout period of 2 days, the subjects underwent the period II of administration and blood collection on the night of Day 3, and the trial method in period II is the same as that in period I.
Vital signs (including body temperature, respiration, pulse, and blood pressure) were measured 1 hour before administration, at 2.0±0.5h, 5.0±0.5h, and 24.0±1.0h after each period of administration. Subjects were hospitalized throughout the trial period and underwent physical examination, vital signs measurement, electrocardiogram, and laboratory-related tests on Day 3 after the period II of dosing (female subjects were required to undergo blood pregnancy tests). Subject Lelt the stage I ward after completing PK sampling and the above examination.
Safety Follow-up: During the Day 8-Day 11 period, subjects will be contacted by telephone to collect information on drug combinations and adverse events after discharge from the study center.
Blood sample collection and processing: Cubital venous blood will be collected at 29 time points: before administration (0 h) (within 1.0h before administration) and 20min, 40min, 1h, 1h20min, 1h40min, 2h, 2h20min, 2h40min, 3h, 3h20min, 3h40min, 4h, 4h20min, 4h40min, 5h, 5h20min, 5h40min, 6h, 6h20min, 6h40min, 7h, 7h20min, 7h40min, 8h, 9h, 10h, 12h and 24h after administration of each period, and 4.0mL of blood was drawn and placed in the labeled EDTA-2K anticoagulant vacuum blood collection tube. Immediately after blood collection, the sampling vessels were gently and completely reversed three times and mixed with anticoagulant and temporarily placed at room temperature until centrifugation, centrifuged at 4℃ (set at 2-8 ℃) at 1700g for 10min. After centrifugation, the samples were removed from the centrifuge, and the plasma was collected and divided into two tubes (detection tube and backup tube) with corresponding labels. The test tube is about 0.8mL, and the remaining plasma is loaded into the backup tube. Blood samples were collected from the beginning, centrifugation was completed within 60 minutes, and plasma was frozen at -20 ° C (-30 ° C ~-10 ° C) or -80 ° C (-90 ° C ~-60 ° C) within 120 minutes. Samples stored in the -20 ° C refrigerator were transferred to the -80 ° C refrigerator for storage after 24 hours of blood collection. After the collection of blood samples of all subjects, the plasma samples of the detection tube will be transferred to the analysis and testing center for blood concentration determination, and the plasma samples of the backup tube will be stored in the clinical research unit or a third party designated by the sponsor.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group T | Experimental | Drug: Test product (T): Ramelteon Modified-Release TabletsTest product (T): Ramelteon Modified-Release Tablets Strength: 8 mg/tablet Batch No.: G12308010 Content: 8 mg/tablet Valid to: 2025-8-16 Storage Conditions:Not higher than 25°C, sealed store Manufacturer: Overseas Pharmaceuticals, Ltd. |
| Group R | Active comparator | Drug: Reference product (R): Ramelteon TabletsReference product (R): Ramelteon Tablets Strength: 8 mg/tablet Batch No.: 12216533 Content: 8 mg/tablet Valid to: 2024-10 Storage Conditions: 25 ° C (77°F) storage, allowing short-term temperature deviations of 15-30 ° C (59-86°F) Manufacturer:Takeda Pharmaceuticals America, Inc. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female subjects aged 18 to 45 years (including 18 and 45 years);
- Male subjects with a body weight ≥ 50.0 kg, and female subjects with a body weight ≥ 45.0 kg; BMI (BMI = body weight (kg)/[height (m)]2) within the range of 19-26.0 kg/m2 (including the critical value);
- Subject who fully understands 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;;
- Subjects who are able to communicate well with the investigator and understand and adhere to the study requirements.
Key exclusion criteria (9 listed)
- Subjects with an allergic history to the study drug or other melatonin or any other component of the study drug, or an allergic history to drug, food , pollen or a specific allergic history (asthma, allergic rhinitis);
- Subjects who have special dietary requirements and cannot accept a unified diet;
- Subjects with a history of dysphagia or any gastrointestinal disorder affecting drug absorption;
- Subjects who cannot tolerate venipuncture , or with needle fainting or blood collection difficulties;
- Subjects with clinically significant hematological, endocrine, cardiovascular, hepatic, renal and pulmonary disorders that may affect drug absorption, distribution, metabolism and excretion;
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 product (T): Ramelteon Modified-Release TabletsOral, take 1 tablet at a time, once a day. | Drug | Group T |
| Reference product (R): Ramelteon TabletsOral, take 1 tablet at a time, once a day. | Drug | Group R |
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.
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.
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.
3 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
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 24 Mar 2025.
- 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.
Shuai He Associate Chief Pharmacist, Doctor principal investigator
The Zhujiang Hospital of Southern Medical University
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 Test product (T): Ramelteon Modified-Release Tablets and Reference product (R): Ramelteon Tablets in people with Chronic Insomnia Characterized, 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 4 inclusion and 9 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 24 Mar 2025. 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?
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 24 Mar 2025.