Depressive DisorderPhase 1AMTL-BENCT03646526
Bioavailability Study of Amitriptyline Hydrochloride Tablets
A Phase 1 study testing Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） and Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） in people with Depressive Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Main Objectives: In Chinese healthy subjects under both fasting and postprandial conditions, amitriptyline hydrochloride tablets (size: 25 mg) produced by Sandoz Inc., US Orange Book, were used as reference preparations. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） and Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2018to 31 Jan 2019
- 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
- Age 18-45 years old (including 18 and 45 years old), both male and female;
- Male subjects weigh more than 50kg (including 50kg) and female subjects weigh more than 45kg (including 45kg); Body mass index [BMI = body weight (kg)/height (m)2] is in the range of 19 to 26 kg/m2;
- According to past medical history, comprehensive physical examination and prescribed laboratory tests, the investigator determined that Healthy subjects;
- Women of childbearing age have a negative blood pregnancy test and are effective from 14 days before dosing to 6 months after the end of study Appropriate contraceptive measures;
- Male volunteers must take effective and appropriate 14 days before dosing until 6 months after the end of the study.
- The contraceptive measures and agrees not to perform sperm donation within six months from the administration until the end of the study;
Show all 9Show fewer
- Fully understand the purpose of the test, the nature of the test, the study procedures, and possible adverse reactions.
- Willing to participate in the trial and sign the informed consent form (the process of obtaining the informed consent accords with GCP regulations);
- Communicate well with the researcher, follow the requirements of the entire study, and be willing to stay in the Phase I clinical research ward as required.
Who cannot join
- Can not tolerate venipuncture, who have a history of dizziness and pinching blood;
- Clearly have a history of allergies to the drug ingredients or similar species or to two or more other drugs Sensitive history and highly sensitive to food and environmental substances;
- Have a history of any serious clinical illness, including but not limited to digestive system, cardiovascular system, respiratory system, Urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, immune system Patients with a history of diseases and metabolic disorders;
- Laboratory tests (blood routine, urine routine, blood chemistry, etc.) and chest X-ray and ECG within 2 weeks before the test Those who have abnormal clinical findings
- Hematological screening (HIV antibody or HBV surface antigen or HCV antibody or TP antibody) positive;
- women who are breastfeeding, pregnant or plan to become pregnant recently;
Show all 22Show fewer
- Female subjects are in lactation or positive pregnancy test during the screening period or during the trial;
- Male and female subjects who have not taken effective contraception or whose spouse plans to have children within six months;
- Persons with mental or legal disabilities;
- Screening for history of prescription drug abuse and/or history of illegal drug abuse within the first 6 months of screening;
- A person who has a history of alcohol abuse within the first 6 months of screening, ie drinking more than 14 units of alcohol per week (1 unit = 12 ounces or 360 mL beer, 1.5 ounces or 45 mL alcohol 40% spirits, 5 ounces or 150mL wine);
- Smoke more than 5 cigarettes per day within 6 months before screening;
- positive for substance abuse screening or alcohol testing;
- Those with a history of hospitalization or surgery within 3 months prior to screening (excluding appendicitis);
- Participate in other drug clinical trials within 3 months before screening;
- Have blood donation or acute blood loss history (≥400 mL) within the first 2 months of screening or 1 after the end of the trial Intended to donate blood during the month;
- Those who used any other medicine within 2 weeks before the test (prescription drugs, non-prescription drugs, any vitamins) Products or herbs);
- Drink more than 1L of tea, coffee, and/or caffeinated beverages daily;
- Those who have special dietary requirements and cannot accept a unified diet;
- Those who are lactose intolerant (have been drinking milk diarrhea);
- Those who do not understand the content of the informed consent and those who do not meet the criteria for the trial enrollment;
- Subjects are poorly adhered to, or the investigator believes there are any individuals who are unfit to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital,ZheJiang Univercity
Hanzhou, Zhejiang, 310000
About this study
Main Objectives: In Chinese healthy subjects under both fasting and postprandial conditions, amitriptyline hydrochloride tablets (size: 25 mg) produced by Sandoz Inc., US Orange Book, were used as reference preparations. A single-dose oral reference preparation and amitriptyline hydrochloride tablets (size: 25 mg) produced by Hunan Dongting Pharmaceutical Co., Ltd., and the calculation of the drug by the time course of amitriptyline and its active metabolite, nortriptyline, in vivo The kinetic parameters were compared, and the relative bioavailability of the two was compared to evaluate bioequivalence, which provided the basis for the bioequivalence study of amitriptyline hydrochloride tablets by Hunan Dongting Pharmaceutical Co., Ltd.
Secondary Objective: To monitor the safety of fasting and postprandial oral test and reference preparations.
Read the detailed description
This clinical study is a single-center, randomized, open clinical study divided into two parts, the first part is the pre-test and the second part is the formal test.
Both pre-test and formal trials were designed using two preparations, two cycles, and a self-crossover controlled trial.
Twelve subjects were enrolled in the pre-test and randomly divided into two groups. Each group received 25 mg of the test preparation or reference preparation in the first day of each cycle, before the administration (0 h) and after the administration 0.5 h, 1.0 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, 7.0 h, 8.0 h, 10.0 h, 12.0 h, 24.0 h, 36.0 h, 48.0 h, 72.0 h, 96.0 h, 120.0 h, 144 h, 168 h, and 192 h blood samples were measured for plasma amitriptyline concentration for bioequivalence analysis, and the concentration of the active metabolite nortriptyline was determined as supportive evidence of comparable efficacy. The pre-test results will provide the basis for formal testing. The cleaning period is 21 ± 1 day.
The formal trials were divided into fasting and postprandial trials to evaluate the bioequivalence of the test preparation and the reference preparation in a single dose of hollow and postprandial administration in healthy Chinese subjects. Fasting and postprandial trials were enrolled in 24 subjects and randomly divided into 2 groups. Each group received 25 mg of the test preparation or reference preparation on the first day of each cycle, before the administration (0 h) and after the administration 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 5.0 h, 6.0 h, 7.0 h, 8.0 h, 10.0 h, 12.0 h, 24.0 h, 36.0 h, 48.0 h, 72.0 h, 96.0 h, 120.0 h and 144 h blood samples were measured for plasma concentrations of amitriptyline for bioequivalence analysis， and the concentration of the active metabolite nortriptyline was determined as supportive evidence of comparable efficacy.. The cleaning period is 21 ± 1 day.
Based on the results of the first part of the pre-test evaluation, the experimental design and sampling time and other contents of the second part of the formal test may require necessary modifications.
The fasting test and the postprandial test in the formal test were carried out independently.
- Conditions
- Depressive Disorder
- Being tested
- Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）, Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）
- Keywords
- Amitriptyline hydrochloride
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）Drug
Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）is a generic product manufactured by Hunan Dongting Pharmaceutical Co., Ltd.
Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）Drug
Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）is a generic product manufactured by Sandoz Inc;
| Study group | Role | What they receive |
|---|---|---|
| Fast group | Experimental | During the study session, healthy subjects will be administered a single dose of Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） or Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） under fasting condition .
cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） or cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） Receives: Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）; Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） |
| Feeding group | Experimental | During the study session, healthy subjects will be administered a single dose of Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） or Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） under feeding condition.
cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） or cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） Receives: Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）; Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Observed Plasma Concentration for amitriptyline
Measured: 144 hours post-dose on Day 1,22
Tmax
Time to Reach the Maximum Plasma Concentration
Measured: 144 hours post-dose on Day 1,22
AUC(0-inf)
Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for amitriptyline
Measured: 144 hours post-dose on Day 1,22
AUC(0-144h)
Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for amitriptyline
Measured: 144 hours post-dose on Day 1,22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start4 Apr 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan DongtingPharm.Co.Ltd
- Responsible party
- Sponsor
- Investigators
- Jian LIU, Master, Study chair, The First Affiliated Hospital,ZheJiang Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646526
- Sponsor's protocol ID
- ZYYY-AMTL-BE-2018-02
- Acronym
- AMTL-BE
- Status last verified
- Jan 2019
- First submitted
- 18 May 2018
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhai Y, Wu L, Zheng Y, Wu M, Huang Y, Huang Q, Shentu J, Zhao Q, Liu J. Bioequivalence Study of Amitriptyline Hydrochloride Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions. Drug Des Devel Ther. 2020 Aug 4;14:3131-3142. doi: 10.2147/DDDT.S258173. eCollection 2020.
PubMed 32801649
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability Study of Amitriptyline Hydrochloride Tablets
- ClinicalTrials.gov ID
- NCT03646526
- Acronym / sponsor ID
- AMTL-BE / ZYYY-AMTL-BE-2018-02
- Conditions
- Depressive Disorder
- Keywords
- Amitriptyline hydrochloride
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hunan DongtingPharm.Co.Ltd
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 24 Aug 2018 (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.
Main Objectives: In Chinese healthy subjects under both fasting and postprandial conditions, amitriptyline hydrochloride tablets (size: 25 mg) produced by Sandoz Inc., US Orange Book, were used as reference preparations. A single-dose oral reference preparation and amitriptyline hydrochloride tablets (size: 25 mg) produced by Hunan Dongting Pharmaceutical Co., Ltd., and the calculation of the drug by the time course of amitriptyline and its active metabolite, nortriptyline, in vivo The kinetic parameters were compared, and the relative bioavailability of the two was compared to evaluate bioequivalence, which provided the basis for the bioequivalence study of amitriptyline hydrochloride tablets by Hunan Dongting Pharmaceutical Co., Ltd.
Secondary Objective: To monitor the safety of fasting and postprandial oral test and reference preparations.
Detailed description
This clinical study is a single-center, randomized, open clinical study divided into two parts, the first part is the pre-test and the second part is the formal test.
Both pre-test and formal trials were designed using two preparations, two cycles, and a self-crossover controlled trial.
Twelve subjects were enrolled in the pre-test and randomly divided into two groups. Each group received 25 mg of the test preparation or reference preparation in the first day of each cycle, before the administration (0 h) and after the administration 0.5 h, 1.0 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, 7.0 h, 8.0 h, 10.0 h, 12.0 h, 24.0 h, 36.0 h, 48.0 h, 72.0 h, 96.0 h, 120.0 h, 144 h, 168 h, and 192 h blood samples were measured for plasma amitriptyline concentration for bioequivalence analysis, and the concentration of the active metabolite nortriptyline was determined as supportive evidence of comparable efficacy. The pre-test results will provide the basis for formal testing. The cleaning period is 21 ± 1 day.
The formal trials were divided into fasting and postprandial trials to evaluate the bioequivalence of the test preparation and the reference preparation in a single dose of hollow and postprandial administration in healthy Chinese subjects. Fasting and postprandial trials were enrolled in 24 subjects and randomly divided into 2 groups. Each group received 25 mg of the test preparation or reference preparation on the first day of each cycle, before the administration (0 h) and after the administration 0.5 h, 1.0 h, 2.0 h, 3.0 h, 4.0 h, 5.0 h, 6.0 h, 7.0 h, 8.0 h, 10.0 h, 12.0 h, 24.0 h, 36.0 h, 48.0 h, 72.0 h, 96.0 h, 120.0 h and 144 h blood samples were measured for plasma concentrations of amitriptyline for bioequivalence analysis， and the concentration of the active metabolite nortriptyline was determined as supportive evidence of comparable efficacy.. The cleaning period is 21 ± 1 day.
Based on the results of the first part of the pre-test evaluation, the experimental design and sampling time and other contents of the second part of the formal test may require necessary modifications.
The fasting test and the postprandial test in the formal test were carried out independently.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast group | Experimental | Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）, Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）During the study session, healthy subjects will be administered a single dose of Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） or Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） under fasting condition . cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） or cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） |
| Feeding group | Experimental | Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）, Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）During the study session, healthy subjects will be administered a single dose of Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） or Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） under feeding condition. cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） or cycle 1 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）/cycle 2 Drug: Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18-45 years old (including 18 and 45 years old), both male and female;
- Male subjects weigh more than 50kg (including 50kg) and female subjects weigh more than 45kg (including 45kg); Body mass index [BMI = body weight (kg)/height (m)2] is in the range of 19 to 26 kg/m2;
- According to past medical history, comprehensive physical examination and prescribed laboratory tests, the investigator determined that Healthy subjects;
- Women of childbearing age have a negative blood pregnancy test and are effective from 14 days before dosing to 6 months after the end of study Appropriate contraceptive measures;
- Male volunteers must take effective and appropriate 14 days before dosing until 6 months after the end of the study.
Key exclusion criteria (22 listed)
- Can not tolerate venipuncture, who have a history of dizziness and pinching blood;
- Clearly have a history of allergies to the drug ingredients or similar species or to two or more other drugs Sensitive history and highly sensitive to food and environmental substances;
- Have a history of any serious clinical illness, including but not limited to digestive system, cardiovascular system, respiratory system, Urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, immune system Patients with a history of diseases and metabolic disorders;
- Laboratory tests (blood routine, urine routine, blood chemistry, etc.) and chest X-ray and ECG within 2 weeks before the test Those who have abnormal clinical findings
- Hematological screening (HIV antibody or HBV surface antigen or HCV antibody or TP antibody) positive;
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 |
|---|---|---|
| Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）is a generic product manufactured by Hunan Dongting Pharmaceutical Co., Ltd. | Drug | Fast group, Feeding group |
| Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）is a generic product manufactured by Sandoz Inc; | Drug | Fast group, Feeding group |
Primary outcome
Cmax
Time frame: 144 hours post-dose on Day 1,22
Maximum Observed Plasma Concentration for amitriptyline
Tmax
Time frame: 144 hours post-dose on Day 1,22
Time to Reach the Maximum Plasma Concentration
AUC(0-inf)
Time frame: 144 hours post-dose on Day 1,22
Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for amitriptyline
AUC(0-144h)
Time frame: 144 hours post-dose on Day 1,22
Area Under the Plasma Concentration-Time Curve From Time 0 to 36 hours Postdose for amitriptyline
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 1 Aug 2019.
- Derived from this study: PubMed 32801649Zhai Y, Wu L, Zheng Y, Wu M, Huang Y, Huang Q, Shentu J, Zhao Q, Liu J. Bioequivalence Study of Amitriptyline Hydrochloride Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions. Drug Des Devel Ther. 2020 Aug 4;14:3131-3142. doi: 10.2147/DDDT.S258173. eCollection 2020.
Related trials for Depressive Disorder
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Recruiting
Understanding the Neural Underpinnings of Risk-Taking Behavior in Psychiatric Disease
Depression - Major Depressive Disorder
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
RecruitingObservational study
Tracking Response to Antidepressants in Advance of Investigational Trials
Major Depressive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
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.
Jian LIU, Master study chair
The First Affiliated Hospital,ZheJiang Univercity
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 Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting） and Amitriptyline Hydrochloride 25Mg Tablet（Sandoz） in people with Depressive Disorder, run by First Affiliated Hospital of Zhejiang University 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 9 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: finished, as of the sponsor's last update on 1 Aug 2019. 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?
Cmax (time frame: 144 hours post-dose on Day 1,22). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03646526, which also lists 1 linked publication.
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 Aug 2019.