Drug Drug InteractionPhase 1NCT05812404
Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 in Healthy Subjects
A Phase 1 study testing DWP14012 and DWC202201 in people with Drug Drug Interaction, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
A randomized, open-label, three-period, three-sequence, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacokinetics of DWC202201 after co-administration of DWP14012 and DWC202201 in healthy subjects Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction
- What is being tested?
- DWP14012 and DWC202201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Oct 2022to 16 Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged ≥ 19 and ≤ 50 years at screening
- Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening
- ※ BMI (kg/m2) = body weight (kg)/[height (m)]2
- Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
- Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.
Who cannot join
- Subjects with a disease or a history related to hepatobiliary system, kidney(severe kidney disorder ect.), nervous system, respiratory system, digestive system, endocrine system, hematology system, circulatory system(Heart failure, Torsades de pointes ect.), unrinary system, psychiatry ect.
- Subjects with digestive disease(gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal disease, Crohn's disease) or history of surgery(except appendectomy, hernia surgery) which can affect on saftey and pharmacodynamics
- Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, antibiotics, etc.
- Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
- Subjects with history of inherited muscle disorders
- Subjects with a history of drug abuse or a positive result of using abusive drugs in the urine drug screen
Show all 13Show fewer
- Subjects who participated in other clinical trials (including bioequivalence studies) within 6 months prior to the first scheduled dose of the IP
- Subjects who donated whole blood within 2 months, donated blood components within 1 month, or received blood transfusion within 1 month prior to the first scheduled dose
- Subjects who are unable to refrain from grapefruit-containing products from 3 days prior to the first scheduled dose until last discharge from hospital
- Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration
- Subjects who are unable to refrain from smoking(>10pieces/day) from 3 days prior to the first scheduled dose until last discharge from hospital
- Subjects with alchoholic disorders or subjects who are unable to refrain from drinking(>21units/week) from 3 days prior to the first scheduled dose until last discharge from hospital
- Subjects who are unable to refrain from caffein(>5units/day) from 3 days prior to the first scheduled dose until last discharge from hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Three-period, Three-sequence, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 After Co-administration of DWP14012 and DWC202201 in Healthy Subjects
A randomized, open-label, three-period, three-sequence, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacokinetics of DWC202201 after co-administration of DWP14012 and DWC202201 in healthy subjects
- Conditions
- Drug Drug Interaction
- Being tested
- DWP14012, DWC202201
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012Drug
Potassium-competitive acid blocker
DWC202201Drug
Atorvastatin Calcium Trihydrate
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | * Treatment A: DWC202201 40 mg qd for 7 days
* Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days
* Treatment C: DWP14012 40 mg qd for 14 days Receives: Drug: DWP14012; Drug: DWC202201 |
| Cohort 2 | Experimental | * Treatment C: DWP14012 40 mg qd for 14 days
* Treatment A: DWC202201 40 mg qd for 7 days
* Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days Receives: Drug: DWP14012; Drug: DWC202201 |
| Cohort 3 | Experimental | * Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days
* Treatment C: DWP14012 40 mg qd for 14 days
* Treatment A: DWC202201 40 mg qd for 7 days Receives: Drug: DWP14012; Drug: DWC202201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing
Measured: [Time Frame: up to 64 days]
Atorvastatin Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing
Measured: [Time Frame: up to 64 days]
Secondary outcomes (36)
Atorvastatin Area under the plasma concentration extrapolated to infinity at steady state (AUC,ss) after DWC202201 multiple dosing
Measured: [Time Frame: up to 64 days]
Atorvastatin Time to peak drug concentration at staedy state (Tmax, ss) after DWC202201 multiple dosing
Measured: [Time Frame: up to 64 days]
Atorvastatin Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing
Measured: [Time Frame: up to 64 days]
Atorvastatin Apparent total body clearance at steady state (CLss/F) after DWC202201 multiple dosing
Measured: [Time Frame: up to 64 days]
Atorvastatin Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing
Measured: [Time Frame: up to 64 days]
Atorvastatin active metabolite Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing
Measured: [Time Frame: up to 64 days]
Atorvastatin active metabolite Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing
Measured: [Time Frame: up to 64 days]
Atorvastatin active metabolite An estimate of the total body clearance at steady state (CL ss/F) after DWC202201 multiple dosing
Measured: [Time Frame: up to 64 days]
Atorvastatin active metabolite Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing
Measured: [Time Frame: up to 64 days]
Atorvastatin active metabolite metabolic ratio after DWC202201 multiple dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan Peak Plasma Concentration (Cmax) after DWP14012 single dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after DWP14012 single dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity(AUCinf) after DWP14012 single dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan The time of peak concentration (Tmax) after DWP14012 single dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan Terminal Half-life (t1/2) after DWP14012 single dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan Apparent Clearance (CL/F) after DWP14012 single dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan Apparent Volume of Distribution After extravascular administration (Vd/F) after DWP14012 single dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan Peak Plasma Concentration at steady state (Cmax,ss) after DWP14012 multiple dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after DWP14012 multiple dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity at steady state (AUCinf,ss) after DWP14012 multiple dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan Time of Maximum Concentration at steady state (Tmax,ss) after DWP14012 multiple dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan Terminal Half-life at steady state (t1/2,ss) after DWP14012 multiple dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan An estimate of the total body clearance at steady state (CL ss/F) after DWP14012 multiple dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan Aapparent volume of distribution after extravascular administration at steady state (Vd,ss/F) after DWP14012 multiple dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan Accumulation ratio after DWP14012 multiple dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan active metabolite Peak Plasma Concentration (Cmax) after single dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after single dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity (AUCinf) after single dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan active metabolite The time of peak concentration (Tmax) after single dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan active metabolite metabolic ratio after single dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan active metabolite Peak Plasma Concentration at steady state (Cmax,ss) after multiple dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan active metabolite AUCtau,ss AUCinf,ss Tmax,ss metabolic ratio
Measured: [Time Frame: up to 64 days]
Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after multiple dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity at steady state (AUCinf,ss) after multiple dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan active metabolite The time of peak concentration at steady state (Tmax,ss) after multiple dosing
Measured: [Time Frame: up to 64 days]
Fexuprazan active metabolite metabolic ratio after multiple dosing
Measured: [Time Frame: up to 64 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start26 Oct 2022
- Primary completion28 Mar 2023
- Study completion16 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug InteractionStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812404
- Sponsor's protocol ID
- DW_DWP14012109
- Status last verified
- Apr 2023
- First submitted
- 14 Nov 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Three-period, Three-sequence, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 After Co-administration of DWP14012 and DWC202201 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05812404
- Acronym / sponsor ID
- DW_DWP14012109
- Conditions
- Drug Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 16 Jun 2023 (estimated)
- First posted
- 13 Apr 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.
A randomized, open-label, three-period, three-sequence, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacokinetics of DWC202201 after co-administration of DWP14012 and DWC202201 in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: DWP14012, Drug: DWC202201* Treatment A: DWC202201 40 mg qd for 7 days * Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days * Treatment C: DWP14012 40 mg qd for 14 days |
| Cohort 2 | Experimental | Drug: DWP14012, Drug: DWC202201* Treatment C: DWP14012 40 mg qd for 14 days * Treatment A: DWC202201 40 mg qd for 7 days * Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days |
| Cohort 3 | Experimental | Drug: DWP14012, Drug: DWC202201* Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days * Treatment C: DWP14012 40 mg qd for 14 days * Treatment A: DWC202201 40 mg qd for 7 days |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults aged ≥ 19 and ≤ 50 years at screening
- Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening
- ※ BMI (kg/m2) = body weight (kg)/[height (m)]2
- Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
- Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.
Key exclusion criteria (13 listed)
- Subjects with a disease or a history related to hepatobiliary system, kidney(severe kidney disorder ect.), nervous system, respiratory system, digestive system, endocrine system, hematology system, circulatory system(Heart failure, Torsades de pointes ect.), unrinary system, psychiatry ect.
- Subjects with digestive disease(gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal disease, Crohn's disease) or history of surgery(except appendectomy, hernia surgery) which can affect on saftey and pharmacodynamics
- Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, antibiotics, etc.
- Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
- Subjects with history of inherited muscle disorders
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 |
|---|---|---|
| DWP14012Potassium-competitive acid blocker | Drug | Cohort 1, Cohort 2, Cohort 3 |
| DWC202201Atorvastatin Calcium Trihydrate | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing
Time frame: [Time Frame: up to 64 days]
Atorvastatin Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing
Time frame: [Time Frame: up to 64 days]
36 secondary outcomes
Atorvastatin Area under the plasma concentration extrapolated to infinity at steady state (AUC,ss) after DWC202201 multiple dosing
Time frame: [Time Frame: up to 64 days]
Atorvastatin Time to peak drug concentration at staedy state (Tmax, ss) after DWC202201 multiple dosing
Time frame: [Time Frame: up to 64 days]
Atorvastatin Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing
Time frame: [Time Frame: up to 64 days]
Atorvastatin Apparent total body clearance at steady state (CLss/F) after DWC202201 multiple dosing
Time frame: [Time Frame: up to 64 days]
Atorvastatin Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing
Time frame: [Time Frame: up to 64 days]
Atorvastatin active metabolite Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing
Time frame: [Time Frame: up to 64 days]
Atorvastatin active metabolite Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing
Time frame: [Time Frame: up to 64 days]
Atorvastatin active metabolite An estimate of the total body clearance at steady state (CL ss/F) after DWC202201 multiple dosing
Time frame: [Time Frame: up to 64 days]
Atorvastatin active metabolite Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing
Time frame: [Time Frame: up to 64 days]
Atorvastatin active metabolite metabolic ratio after DWC202201 multiple dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan Peak Plasma Concentration (Cmax) after DWP14012 single dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after DWP14012 single dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity(AUCinf) after DWP14012 single dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan The time of peak concentration (Tmax) after DWP14012 single dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan Terminal Half-life (t1/2) after DWP14012 single dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan Apparent Clearance (CL/F) after DWP14012 single dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan Apparent Volume of Distribution After extravascular administration (Vd/F) after DWP14012 single dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan Peak Plasma Concentration at steady state (Cmax,ss) after DWP14012 multiple dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after DWP14012 multiple dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity at steady state (AUCinf,ss) after DWP14012 multiple dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan Time of Maximum Concentration at steady state (Tmax,ss) after DWP14012 multiple dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan Terminal Half-life at steady state (t1/2,ss) after DWP14012 multiple dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan An estimate of the total body clearance at steady state (CL ss/F) after DWP14012 multiple dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan Aapparent volume of distribution after extravascular administration at steady state (Vd,ss/F) after DWP14012 multiple dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan Accumulation ratio after DWP14012 multiple dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan active metabolite Peak Plasma Concentration (Cmax) after single dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after single dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity (AUCinf) after single dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan active metabolite The time of peak concentration (Tmax) after single dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan active metabolite metabolic ratio after single dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan active metabolite Peak Plasma Concentration at steady state (Cmax,ss) after multiple dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan active metabolite AUCtau,ss AUCinf,ss Tmax,ss metabolic ratio
Time frame: [Time Frame: up to 64 days]
Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after multiple dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity at steady state (AUCinf,ss) after multiple dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan active metabolite The time of peak concentration at steady state (Tmax,ss) after multiple dosing
Time frame: [Time Frame: up to 64 days]
Fexuprazan active metabolite metabolic ratio after multiple dosing
Time frame: [Time Frame: up to 64 days]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWP14012 and DWC202201 in people with Drug Drug Interaction, run by Daewoong Pharmaceutical Co. LTD. 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 13 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 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing (time frame: [Time Frame: up to 64 days]). The study lists 2 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 13 Apr 2023.