HealthyPhase 1NCT05463497

To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers

A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Healthy, run by JW Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Treatment A, Treatment B and Treatment C
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSouth Korea
Study dates: 17 Jan 2022to 23 Mar 2022
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers

Who cannot join

Subjects does not meet the Inclusion Criteria

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Jeonbuk National University Hospita
Jeonju, Jeollabuk-do, 54907

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple-dose, 2x3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction of JW0201 and C2103 or C2104 After Oral Administration in Healthy Adults

A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults

Read the detailed description

To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2103 compared to the case of each single administration in healthy adults.
To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2104 compared to the case of each single administration in healthy adults.

Conditions: Healthy
Being tested: Treatment A, Treatment B, Treatment C, Treatment D, Treatment E

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment ADrug
JW0201: single administration, Tablet, Oral, BID for 5 days
Treatment BDrug
C2103: single administration, Tablet, Oral, BID for 5 days
Treatment CDrug
JW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days
Treatment DDrug
C2104 : single administration, Tablet, Oral, QD for 5 days
Treatment EDrug
JW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days

Study groups in NCT05463497
Study group	Role	What they receive
Group 1(N=10)	Other	Treatment A for Period 1 Treatment C for Period 2 Treatment B for Period 3 *Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3 Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Group 2(N=10)	Other	Treatment B for Period 1 Treatment A for Period 2 Treatment C for Period 3 *Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3 Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Group 3(N=10)	Other	Treatment A for Period I Treatment E Treatment D *Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3 Receives: Drug: Treatment A; Drug: Treatment D; Drug: Treatment E
Group 4(N=10)	Other	Treatment D for Period 1 Treatment A for Period 2 Treatment E for Period 3 *Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3 Receives: Drug: Treatment A; Drug: Treatment D; Drug: Treatment E

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax,ss
Cmax,ss of each drug
Measured: up to 12hour(or 24hour) after administration
AUCτ,ss
AUCτ,ss of each drug
Measured: up to 12hour(or 24hour) after administration

Secondary outcomes (5)

Cmin,ss
Cmin,ss of each drug
Measured: up to 12hour(or 24hour) after administration
Tmax,ss
Tmax,ss of each drug
Measured: up to 12hour(or 24hour) after administration
CLss/F
CLss/F of each drug
Measured: up to 12hour(or 24hour) after administration
Vdss/F
Vdss/F of each drug
Measured: up to 12hour(or 24hour) after administration
fluctuation
fluctuation of each drug
Measured: up to 12hour(or 24hour) after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jan 202223 Mar 2022

First posted19 Jul 2022
Study start17 Jan 2022
Primary completion16 Mar 2022
Study completion23 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
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: Sequential
Model description: A randomized, open-label, multiple-dose, 2x3 crossover clinical trial
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05463497
Sponsor's protocol ID: JW21101
Status last verified: Jul 2022
First submitted: 3 Jul 2022
Last updated: 19 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Multiple-dose, 2x3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction of JW0201 and C2103 or C2104 After Oral Administration in Healthy Adults
ClinicalTrials.gov ID: NCT05463497
Acronym / sponsor ID: JW21101
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: JW PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 17 Jan 2022 (actual)
Primary completion: 16 Mar 2022 (actual)
Study completion: 23 Mar 2022 (actual)
First posted: 19 Jul 2022 (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, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults

Detailed description

To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2103 compared to the case of each single administration in healthy adults.
To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2104 compared to the case of each single administration in healthy adults.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4
Model description: A randomized, open-label, multiple-dose, 2x3 crossover clinical trial

Arm	Type	Receives
Group 1(N=10)	Other	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatment A for Period 1 Treatment C for Period 2 Treatment B for Period 3 *Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3
Group 2(N=10)	Other	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatment B for Period 1 Treatment A for Period 2 Treatment C for Period 3 *Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3
Group 3(N=10)	Other	Drug: Treatment A, Drug: Treatment D, Drug: Treatment ETreatment A for Period I Treatment E Treatment D *Washout period : No washout period between period 1 and 2, more than 7 days between period 2 and 3
Group 4(N=10)	Other	Drug: Treatment A, Drug: Treatment D, Drug: Treatment ETreatment D for Period 1 Treatment A for Period 2 Treatment E for Period 3 *Washout period : more than 7 days between period 1 and 2, no washout period between period 2 and 3

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy volunteers

Key exclusion criteria (1 listed)

Subjects does not meet the Inclusion Criteria

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
Treatment AJW0201: single administration, Tablet, Oral, BID for 5 days	Drug	Group 1(N=10), Group 2(N=10), Group 3(N=10), Group 4(N=10)
Treatment BC2103: single administration, Tablet, Oral, BID for 5 days	Drug	Group 1(N=10), Group 2(N=10)
Treatment CJW0201 and C2103 : combination administration, Tablet, Oral, BID for 5 days	Drug	Group 1(N=10), Group 2(N=10)
Treatment DC2104 : single administration, Tablet, Oral, QD for 5 days	Drug	Group 3(N=10), Group 4(N=10)
Treatment EJW0201 and C2104 : combination administration, JW0201 twice a day and C2104 once a day for 5days	Drug	Group 3(N=10), Group 4(N=10)

Primary outcome

Cmax,ss
Time frame: up to 12hour(or 24hour) after administration
Cmax,ss of each drug
AUCτ,ss
Time frame: up to 12hour(or 24hour) after administration
AUCτ,ss of each drug

5 secondary outcomes

Cmin,ss
Time frame: up to 12hour(or 24hour) after administration
Tmax,ss
Time frame: up to 12hour(or 24hour) after administration
CLss/F
Time frame: up to 12hour(or 24hour) after administration
Vdss/F
Time frame: up to 12hour(or 24hour) after administration
fluctuation
Time frame: up to 12hour(or 24hour) after 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 19 Jul 2022.

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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-Gul Kim, PI principal investigator

Jeonbuk National University Hospita

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 Treatment A, Treatment B and Treatment C in people with Healthy, run by JW 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 1 inclusion and 1 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 19 Jul 2022. 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?

Cmax,ss (time frame: up to 12hour(or 24hour) after administration). 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?

On the ClinicalTrials.gov record for NCT05463497.

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 19 Jul 2022.