DyslipidemiasPhase 1NCT03382756
A Clinical Trial to Assess the Effects of Food on the Bioavailability of CKD-337
A Phase 1 study testing High fat diet and CKD-337 in people with Dyslipidemias, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A cross-over, randomized and open-label clinical trial to evaluate the effects of food on the bioavailability of CKD-337 after a single oral dose in healthy male subjects Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- High fat diet and CKD-337
- 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 siteSouth Korea
- Study dates
- 12 Oct 2017to 7 Nov 2017
- 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 19 and 45 years
- Body mass index between 17.5 and 30.5 kg/m², body weight more than 55kg
- Subject who doesn't have chronic disease, pathological symptoms or findings
- Subject who is suitable for the clinical trial determined by laboratory tests(serum test, hematology test, blood chemistry, urinalysis test etc.), Vital Sign, ECG test at the time of screening
- Subject who fully understand the clinical trial after in-depth explanation, decide to join the clinical trials and sign on an inform consent from willingly.
Who cannot join
- Subject who has a clinically significant disease such as hepatic, kidneys, neurological, respiratory, endocrine, hemato-oncology, urinary, cardiovascular, musculoskeletal or psychiatric diseases and who has medical histories listed below.
- Gallbladder disease including cholelithiasis, severe hepatic impairment
- Acute/chronic pancreatitis due to hypertriglyceridemia
- Pulmonary embolism or interstitial lung disease
- Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Hypoalbuminemia
Show all 31Show fewer
- Alcoholics
- Predisposition to rhabdomyolysis
- Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption
- Subject who has hypersensitivity to the drugs containing choline fenofibrate, fenofibrate or atorvastatin, or other drugs such as aspirin, fenofibrate series, antibiotics
- Subject who has the following clinical significant findings in the EKG at the time of screening
- QTc(Q-T interval corrected for heart rate) > 450ms
- PR interval(The interval between the beginning of the P wave and the beginning of the QRS complex in ECG) > 200msec
- QRS duration(The duration of the QRS wave in ECG) > 120msec
- Subject whose results of the clinical laboratory tests are included in the following categories
- CPK(Creatinine Phospho-Kinase) > 2x upper limit of normal range
- Liver function test (AST;Aspartate Transaminase, ALT;Alanine Transaminase, ALP;Alkaline phosphatase, Total bilirubin, γ-GT;Gamma-Glutamyl Transferase) > 2 x upper limit of normal range
- eGFR(Estimated Glomerular Filtration Rate) < 60 mL/min/1.73m² Calculated by MDRD(Modification of Diet in Renal Disease)
- Systolic blood pressure ≥ 160mmHg(millimeter of mercury) or ≤ 100mmHg(millimeter of mercury) , Diastolic blood pressure ≥ 95mmHg(millimeter of mercury) or ≤ 60mmHg(millimeter of mercury) at the time of screening
- History of drug abuse or a positive reaction for drug abuse examined by urinalysis at the time of screening
- Subject who took medicines that are known to significantly induce or inhibit drug metabolizing enzymes, including barbiturates, within 30 days prior to the first dose of medication
- Those who has experienced photoallergy or phototoxicity during treatment with fibrates or ketoprofen
- Subject who took ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 10 days prior to the first dose of medication
- Subject who took the medication involved in other clinical trials within 3 months prior to the first dose of medication
- Subject who donated whole conducted blood donation within 2 months or component blood donation or blood transfusion within 1 month prior to the first dose of medication
- Subject who drinks alcohol more than 21 units per a week (1unit=10g of pure alcohol) continuously within 6 month prior to the first dose of medication or Who can not stop drinking alcohol during the clinical trial
- Smoker(> 10 cigarettes/day) for the last 3 months or who can not stop smoking during the clinical trial
- Subject who consumed food containing grapefruit within 48 hours prior to the first dose of medication or who can not stop consumption it until EOS(End of study)
- Subject who consumed food containing caffeine(e.g. coffee, green tea etc.) within 24 hours prior to the first dose of medication or who can not stop consumption it until discharge
- Subject who do not use a reliable contraception or who plans a pregnancy during the clinical trial
- Subject who has unsuitable conditions decided by investigator's judgement including clinical laboratory result
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-over, Randomized and Open-label Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-337 After a Single Oral Dose in Healthy Male Subjects
A cross-over, randomized and open-label clinical trial to evaluate the effects of food on the bioavailability of CKD-337 after a single oral dose in healthy male subjects
Read the detailed description
This clinical trial is to evaluate the effects of food on pharmacokinetics of CKD-337.
Sixteen male subjects are divided into two groups. A group of subjects are administered a single oral dose of CKD-337 after ingesting high fat meal and the other take same investigational product (IP) in fasting condition. Then their blood is drawn on a fixed schedule to analyse bioavailability of CKD-337.
Finishing the first treatment period, the two groups switch food conditions and initiate the second period. The group of people that were administered CKD-337 with food are then dosed the same IP in fasting condition, and the other group undergo vice versa.
Each treatment period was separated by a washout period of at least 7 days.
- Conditions
- Dyslipidemias
- Being tested
- High fat diet, CKD-337
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat dietDietary supplement
A diet consisting of more than 900kcal and 35% of fat
CKD-337Drug
Also called Atorvastatin Calcium Trihydrate + Choline Fenofibrate
Test Drug
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Period 1: 1 capsule of test drug(CKD-337) administered under fasting condition
Period 2: 1 capsule of test drug(CKD-337) under high fat diet condition Receives: Dietary Supplement: High fat diet; Drug: CKD-337 |
| Group B | Experimental | Period 1: 1 capsule of test drug(CKD-337) under high fat diet fed condition
Period 2: 1 capsule of test drug (CKD-337) administered under fasting condition Receives: Dietary Supplement: High fat diet; Drug: CKD-337 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t of Atorvastatin
Area under the plasma concentration of Atorvastatin versus time curve from time zero to time of last quantifiable concentration
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Cmax of Atorvastatin
Maximum plasma concentration of Atorvastatin
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
AUCt of Fenofibric acid
Area under the plasma concentration of Fenofibric acid versus time curve from time zero to time of last quantifiable concentration
Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
Cmax of Fenofibric acid
Maximum plasma concentration of Fenofibric acid
Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
Secondary outcomes (17)
AUCinf of Atorvastatin
Area under the plasma concentration of Atorvastatin versus time curve from time zero to time infinity
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Tmax of Atorvastatin
Time to maximum concentration of of Atorvastatin
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
T 1/2 of Atorvastatin
Apparent terminal half-life of Atorvastatin
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
CL/F of Atorvastatin
Total body clearance of Atorvastatin
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Vd/F of Atorvastatin
Apparent volume of distribution of Atorvastatin
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
AUCinf of Fenofibric acid
Area under the plasma concentration of Fenofibric acid versus time curve from time zero to time infinity
Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
Tmax of Fenofibric acid
Time to maximum concentration of Fenofibric acid
Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
T 1/2 of Fenofibric acid
Apparent terminal half-life of Fenofibric acid
Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
CL/F of Fenofibric acid
Total body clearance of Fenofibric acid
Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
Vd/F of Fenofibric acid
Apparent volume of distribution of Fenofibric acid
Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
AUC0-t of 2-hydroxy atorvastatin
Area under the plasma concentration of 2-hydroxy atorvastatin versus time curve from time zero to time of last quantifiable concentration
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Cmax of 2-hydroxy atorvastatin
Maximum concentration attained of 2-hydroxy atorvastatin
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
AUCinf of 2-hydroxy atorvastatin
Area under the plasma concentration of 2-hydroxy atorvastatin versus time curve from time zero to time infinity
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Tmax of 2-hydroxy atorvastatin
Time to maximum concentration 2-hydroxy atorvastatin
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
T 1/2 of 2-hydroxy atorvastatin
Apparent terminal half-life of 2-hydroxy atorvastatin
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
CL/F of 2-hydroxy atorvastatin
Total body clearance of 2-hydroxy atorvastatin
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Vd/F of 2-hydroxy atorvastatin
Apparent volume of distribution of 2-hydroxy atorvastatin
Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start12 Oct 2017
- Primary completion2 Nov 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Kyu Park, Professor, Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382756
- Sponsor's protocol ID
- 146FDI17001
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2017
- Last updated
- 27 Dec 2017
- 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 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-over, Randomized and Open-label Clinical Trial to Evaluate the Effects of Food on the Bioavailability of CKD-337 After a Single Oral Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03382756
- Acronym / sponsor ID
- 146FDI17001
- Conditions
- Dyslipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 26 Dec 2017 (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 cross-over, randomized and open-label clinical trial to evaluate the effects of food on the bioavailability of CKD-337 after a single oral dose in healthy male subjects
Detailed description
This clinical trial is to evaluate the effects of food on pharmacokinetics of CKD-337.
Sixteen male subjects are divided into two groups. A group of subjects are administered a single oral dose of CKD-337 after ingesting high fat meal and the other take same investigational product (IP) in fasting condition. Then their blood is drawn on a fixed schedule to analyse bioavailability of CKD-337.
Finishing the first treatment period, the two groups switch food conditions and initiate the second period. The group of people that were administered CKD-337 with food are then dosed the same IP in fasting condition, and the other group undergo vice versa.
Each treatment period was separated by a washout period of at least 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: High fat diet, Drug: CKD-337Period 1: 1 capsule of test drug(CKD-337) administered under fasting condition Period 2: 1 capsule of test drug(CKD-337) under high fat diet condition |
| Group B | Experimental | Dietary Supplement: High fat diet, Drug: CKD-337Period 1: 1 capsule of test drug(CKD-337) under high fat diet fed condition Period 2: 1 capsule of test drug (CKD-337) administered under fasting condition |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects between the ages of 19 and 45 years
- Body mass index between 17.5 and 30.5 kg/m², body weight more than 55kg
- Subject who doesn't have chronic disease, pathological symptoms or findings
- Subject who is suitable for the clinical trial determined by laboratory tests(serum test, hematology test, blood chemistry, urinalysis test etc.), Vital Sign, ECG test at the time of screening
- Subject who fully understand the clinical trial after in-depth explanation, decide to join the clinical trials and sign on an inform consent from willingly.
Key exclusion criteria (31 listed)
- Subject who has a clinically significant disease such as hepatic, kidneys, neurological, respiratory, endocrine, hemato-oncology, urinary, cardiovascular, musculoskeletal or psychiatric diseases and who has medical histories listed below.
- Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption
- Subject who has hypersensitivity to the drugs containing choline fenofibrate, fenofibrate or atorvastatin, or other drugs such as aspirin, fenofibrate series, antibiotics
- Subject who has the following clinical significant findings in the EKG at the time of screening
- Subject whose results of the clinical laboratory tests are included in the following categories
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 |
|---|---|---|
| High fat dietA diet consisting of more than 900kcal and 35% of fat | Dietary supplement | Group A, Group B |
| CKD-337Also: Atorvastatin Calcium Trihydrate + Choline FenofibrateTest Drug | Drug | Group A, Group B |
Primary outcome
AUC0-t of Atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Area under the plasma concentration of Atorvastatin versus time curve from time zero to time of last quantifiable concentration
Cmax of Atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Maximum plasma concentration of Atorvastatin
AUCt of Fenofibric acid
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
Area under the plasma concentration of Fenofibric acid versus time curve from time zero to time of last quantifiable concentration
Cmax of Fenofibric acid
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
Maximum plasma concentration of Fenofibric acid
17 secondary outcomes
AUCinf of Atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Tmax of Atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
T 1/2 of Atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
CL/F of Atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Vd/F of Atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
AUCinf of Fenofibric acid
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
Tmax of Fenofibric acid
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
T 1/2 of Fenofibric acid
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
CL/F of Fenofibric acid
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
Vd/F of Fenofibric acid
Time frame: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, and 96hr after drug administration
AUC0-t of 2-hydroxy atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Cmax of 2-hydroxy atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
AUCinf of 2-hydroxy atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Tmax of 2-hydroxy atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
T 1/2 of 2-hydroxy atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
CL/F of 2-hydroxy atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
Vd/F of 2-hydroxy atorvastatin
Time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration
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 27 Dec 2017.
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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.
Min Kyu Park, Professor principal investigator
Dong-A University Hospital
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 High fat diet and CKD-337 in people with Dyslipidemias, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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 31 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 27 Dec 2017. 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 South Korea. 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?
AUC0-t of Atorvastatin (time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, and 48hr after drug administration). 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?
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 27 Dec 2017.