PainPhase 1NCT04375865
Evaluating the Pharmacokinetic Interactions and Safety Between AD-2111 and AD-2112
A Phase 1 study testing AD-2111 and AD-2112 in people with Pain, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
A phase I clinical trial to evaluate the pharmacokinetic interactions and safety between AD-2111 and AD-2112 Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- AD-2111 and AD-2112
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2020to 16 Jul 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Adult aged 19 and more at the time of screening visit
- Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit
Who cannot join
- As a result of laboratory tests, the following figures: ALT or AST or total bilirubin > 1.5 times upper limit of normal range
- As a result of laboratory tests, the following figures: Creatinine clearance < 80mL/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between AD-2111 and AD-2112 in Healthy Adult Subjects
A phase I clinical trial to evaluate the pharmacokinetic interactions and safety between AD-2111 and AD-2112
Read the detailed description
Purpose: pharmacokinetic interactions and safety of AD-2111 and AD-2112 in healthy adult volunteers Condition or disease : Pain Intervention/treatment Drug : AD-2111(Celecoxib 200mg), AD-2112(Tramadol 150mg) Phase : Phase 1
- Conditions
- Pain
- Being tested
- AD-2111, AD-2112
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-2111Drug
celecoxib 200mg
AD-2112Drug
Tramadol 150mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Period1: Celecoxib 200mg Period2: Tramadol 150mg Period3: Celecoxib 200mg + Tramadol 150mg Receives: Drug: AD-2111; Drug: AD-2112 |
| Treatment B | Experimental | Period1: Celecoxib 200mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Tramadol 150mg Receives: Drug: AD-2111; Drug: AD-2112 |
| Treatment C | Experimental | Period1: Tramadol 150mg Period2: Celecoxib 200mg Period3: Celecoxib 200mg + Tramadol 150mg Receives: Drug: AD-2111; Drug: AD-2112 |
| Treatment D | Experimental | Period1: Tramadol 150mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Celecoxib 200mg Receives: Drug: AD-2111; Drug: AD-2112 |
| Treatment E | Experimental | Period1: Celecoxib 200mg + Tramadol 150mg Period2: Celecoxib 200mg Period3: Tramadol 150mg Receives: Drug: AD-2111; Drug: AD-2112 |
| Treatment F | Active comparator | Period1: Celecoxib 200mg + Tramadol 150mg Period2: Tramadol 150mg Period3: Celecoxib 200mg Receives: Drug: AD-2111; Drug: AD-2112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve in time plot (AUCt)
AUCt of the total ingredient of Celecoxib, Tramadol
Measured: pre-dose to 72 hours
Peak Plasma Concentration (Cmax)
Cmax of the total ingredient of Celecoxib, Tramadol
Measured: pre-dose to 72 hours
Secondary outcomes (7)
Area under the curve in time plot (AUCinf)
AUCinf of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Measured: pre-dose to 72 hours
Time to reach Cmax(Tmax)
Tmax of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Measured: pre-dose to 72 hours
Effective half-life(t1/2)
t1/2 of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Measured: pre-dose to 72 hours
Clearance(CL/F)
CL/F of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Measured: pre-dose to 72 hours
Volume of distribution(Vd/F)
Vd/F of the total ingredient of Celecoxib, Tramadol, O-desmethyltramadol
Measured: pre-dose to 72 hours
Area under the curve in time plot (AUCt) of O-desmethyltramadol
AUCt of the total ingredient of O-desmethyltramadol
Measured: pre-dose to 72 hours
Peak Plasma Concentration (Cmax) of O-desmethyltramadol
Cmax of the total ingredient of O-desmethyltramadol
Measured: pre-dose to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start30 May 2020
- Primary completion16 Jul 2020
- Study completion16 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young-Ran Yoon, M.D., Ph.D, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375865
- Sponsor's protocol ID
- AD-211DDI
- Status last verified
- Nov 2020
- First submitted
- 27 Apr 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interactions and Safety Between AD-2111 and AD-2112 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04375865
- Acronym / sponsor ID
- AD-211DDI
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2020 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 6 May 2020 (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 phase I clinical trial to evaluate the pharmacokinetic interactions and safety between AD-2111 and AD-2112
Detailed description
Purpose: pharmacokinetic interactions and safety of AD-2111 and AD-2112 in healthy adult volunteers Condition or disease : Pain Intervention/treatment Drug : AD-2111(Celecoxib 200mg), AD-2112(Tramadol 150mg) Phase : Phase 1
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: AD-2111, Drug: AD-2112Period1: Celecoxib 200mg Period2: Tramadol 150mg Period3: Celecoxib 200mg + Tramadol 150mg |
| Treatment B | Experimental | Drug: AD-2111, Drug: AD-2112Period1: Celecoxib 200mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Tramadol 150mg |
| Treatment C | Experimental | Drug: AD-2111, Drug: AD-2112Period1: Tramadol 150mg Period2: Celecoxib 200mg Period3: Celecoxib 200mg + Tramadol 150mg |
| Treatment D | Experimental | Drug: AD-2111, Drug: AD-2112Period1: Tramadol 150mg Period2: Celecoxib 200mg + Tramadol 150mg Period3: Celecoxib 200mg |
| Treatment E | Experimental | Drug: AD-2111, Drug: AD-2112Period1: Celecoxib 200mg + Tramadol 150mg Period2: Celecoxib 200mg Period3: Tramadol 150mg |
| Treatment F | Active comparator | Drug: AD-2111, Drug: AD-2112Period1: Celecoxib 200mg + Tramadol 150mg Period2: Tramadol 150mg Period3: Celecoxib 200mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Adult aged 19 and more at the time of screening visit
- Body mass index (BMI) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit
Key exclusion criteria (2 listed)
- As a result of laboratory tests, the following figures: ALT or AST or total bilirubin > 1.5 times upper limit of normal range
- As a result of laboratory tests, the following figures: Creatinine clearance < 80mL/min
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 |
|---|---|---|
| AD-2111celecoxib 200mg | Drug | Treatment A, Treatment B, Treatment C, Treatment D, Treatment E, Treatment F |
| AD-2112Tramadol 150mg | Drug | Treatment A, Treatment B, Treatment C, Treatment D, Treatment E, Treatment F |
Primary outcome
Area under the curve in time plot (AUCt)
Time frame: pre-dose to 72 hours
AUCt of the total ingredient of Celecoxib, Tramadol
Peak Plasma Concentration (Cmax)
Time frame: pre-dose to 72 hours
Cmax of the total ingredient of Celecoxib, Tramadol
7 secondary outcomes
Area under the curve in time plot (AUCinf)
Time frame: pre-dose to 72 hours
Time to reach Cmax(Tmax)
Time frame: pre-dose to 72 hours
Effective half-life(t1/2)
Time frame: pre-dose to 72 hours
Clearance(CL/F)
Time frame: pre-dose to 72 hours
Volume of distribution(Vd/F)
Time frame: pre-dose to 72 hours
Area under the curve in time plot (AUCt) of O-desmethyltramadol
Time frame: pre-dose to 72 hours
Peak Plasma Concentration (Cmax) of O-desmethyltramadol
Time frame: pre-dose to 72 hours
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 6 Nov 2020.
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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.
Young-Ran Yoon, M.D., Ph.D principal investigator
Kyungpook National 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 AD-2111 and AD-2112 in people with Pain, run by Addpharma Inc. 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 2 inclusion and 2 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 6 Nov 2020. 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?
Area under the curve in time plot (AUCt) (time frame: pre-dose to 72 hours). 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 6 Nov 2020.