PainPhase 1NCT01880125
Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination
A Phase 1 study testing Tramadol HCI/Acetaminophen in people with Pain, run by Yungjin Pharm. Co., Ltd..
Trial summary
1. Objective: To evaluate the pharmacokinetic profiles of an SR 75 mg tramadol/650 mg acetaminophen formulation compared with an immediate release (IR) 37.5 mg tramadol/325 mg acetaminophen formulation after a single dose and at steady state 2. Subjects: Healthy subject 3. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Tramadol HCI/Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to May 2012
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects between the ages of 20 and 45 years
- Subjects weighed ≥ 45 kg and were within 20% of their ideal body weight
- No clinically relevant abnormalities identified by vital sign measurement, 12-lead electrocardiography and routine laboratory test
Who cannot join
- Hypersensitivity or histories of sensitivity to either tramadol or acetaminophen
- Evidence or histories of clinically significant renal, digestive, respiratory, musculoskeletal, endocrine, psychiatric, neurological, hematological or cardiovascular diseases
- Taking any prescription or herbal medicines within 2 weeks before the study or any over-the-counter medication within 1 week before the study
- Systolic blood pressure (SBP) ≥ 160 mmHg or ≤ 100 mmHg or diastolic blood pressure (DBP) ≥ 95 mmHg or ≤ 60 mmHg
- Any surgical or medical conditions that could affect drug absorption
About this study
Official title: Clinical Trial to Compare the Pharmacokinetics Profile of YJAT Sustained Release Tablet and ULTRACET® Immediate Release Tablet After Oral Administration to Healthy Male Subjects
- Objective: To evaluate the pharmacokinetic profiles of an SR 75 mg tramadol/650 mg acetaminophen formulation compared with an immediate release (IR) 37.5 mg tramadol/325 mg acetaminophen formulation after a single dose and at steady state
- Subjects: Healthy subject
- Methods: A phase I study to evaluate the pharmacokinetic sustained release and immediate release treatment profiles at steady state.
Read the detailed description
This study was open, randomized, 2-period, 2-treatment multiple-dose crossover study of immediate release treatment and sustained release treatment was designed to assess the pharmacokinetics after a 2-day repeated administration in which the steady state was achieved.
- Conditions
- Pain
- Being tested
- Tramadol HCI/Acetaminophen
- Keywords
- Tramadol, Acetaminophen, Pharmacokinetics, Sustained release, Immediate release
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HCI/AcetaminophenDrug
Also called ULTRACET immediate release tablet, YJAT sustained release tablet
Test drug: Tramadol HCI/Acetaminophen 75/650mg, two times daily. Reference drug: Tramadol HCI/Acetaminophen 37.5/325 mg, four times daily.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Period 1: Tramadol HCI/Acetaminophen 37.5/325mg PO once with water 240ml at fasted state Period 2: Tramadol HCI/Acetaminophen 75/650mg PO once once with water 240ml at fasted state Receives: Drug: Tramadol HCI/Acetaminophen |
| Group B | Other | Period 1: Tramadol HCI/Acetaminophen 75/650mg PO once once with water 240ml at fasted state Period 2: Tramadol HCI/Acetaminophen 37.5/325mg PO once with water 240ml at fasted state Receives: Drug: Tramadol HCI/Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state
Bio-equivalence of Cmax at steady state of tramadol and acetaminophen
Measured: 0 to 36 hour
Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state
Bio-equivalence of AUC at steady state of tramadol and acetaminophen
Measured: 0 to 36 hour
Secondary outcomes (7)
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
Tmax of tramadol and acetaminophen at steady state.
Measured: 0 to 36 hour
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
Half-life of tramadol and acetaminophen at steady state.
Measured: 0 to 36 hour
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
Accumulation index of tramadol and acetaminophen at steady state.
Measured: 0 to 36 hour
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
Cmax of O-desmethyltramadol at steady state
Measured: 0 to 36 hour
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
AUC of O-desmethyltramadol at steady state
Measured: 0 to 36 hour
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
Tmax of O-desmethyltramadol at steady state
Measured: 0 to 36 hour
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
Half-life of O-desmethyltramadol at steady state
Measured: 0 to 36 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
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 PainStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yungjin Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chonbuk National University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880125
- Sponsor's protocol ID
- YJ4-101
- Status last verified
- Apr 2021
- First submitted
- 13 Jun 2013
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Im YJ, Jeon JY, Kim EY, Kim Y, Oh DJ, Yoo JS, Shin DH, Chae SW, Kim MG. An assessment of the pharmacokinetics of a sustained-release formulation of a tramadol/acetaminophen combination in healthy subjects. Clin Ther. 2015 Feb 1;37(2):376-89. doi: 10.1016/j.clinthera.2014.12.007. Epub 2015 Jan 22.
PubMed 25618318
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Compare the Pharmacokinetics Profile of YJAT Sustained Release Tablet and ULTRACET® Immediate Release Tablet After Oral Administration to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01880125
- Acronym / sponsor ID
- YJ4-101
- Conditions
- Pain
- Keywords
- Tramadol, Acetaminophen, Pharmacokinetics, Sustained release, Immediate release
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Yungjin Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chonbuk National University Hospital
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Jun 2013 (estimated)
- 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.
- Objective: To evaluate the pharmacokinetic profiles of an SR 75 mg tramadol/650 mg acetaminophen formulation compared with an immediate release (IR) 37.5 mg tramadol/325 mg acetaminophen formulation after a single dose and at steady state
- Subjects: Healthy subject
- Methods: A phase I study to evaluate the pharmacokinetic sustained release and immediate release treatment profiles at steady state.
Detailed description
This study was open, randomized, 2-period, 2-treatment multiple-dose crossover study of immediate release treatment and sustained release treatment was designed to assess the pharmacokinetics after a 2-day repeated administration in which the steady state was achieved.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Drug: Tramadol HCI/AcetaminophenPeriod 1: Tramadol HCI/Acetaminophen 37.5/325mg PO once with water 240ml at fasted state Period 2: Tramadol HCI/Acetaminophen 75/650mg PO once once with water 240ml at fasted state |
| Group B | Other | Drug: Tramadol HCI/AcetaminophenPeriod 1: Tramadol HCI/Acetaminophen 75/650mg PO once once with water 240ml at fasted state Period 2: Tramadol HCI/Acetaminophen 37.5/325mg PO once with water 240ml at fasted state |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects between the ages of 20 and 45 years
- Subjects weighed ≥ 45 kg and were within 20% of their ideal body weight
- No clinically relevant abnormalities identified by vital sign measurement, 12-lead electrocardiography and routine laboratory test
Key exclusion criteria (5 listed)
- Hypersensitivity or histories of sensitivity to either tramadol or acetaminophen
- Evidence or histories of clinically significant renal, digestive, respiratory, musculoskeletal, endocrine, psychiatric, neurological, hematological or cardiovascular diseases
- Taking any prescription or herbal medicines within 2 weeks before the study or any over-the-counter medication within 1 week before the study
- Systolic blood pressure (SBP) ≥ 160 mmHg or ≤ 100 mmHg or diastolic blood pressure (DBP) ≥ 95 mmHg or ≤ 60 mmHg
- Any surgical or medical conditions that could affect drug absorption
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 |
|---|---|---|
| Tramadol HCI/AcetaminophenAlso: ULTRACET immediate release tablet, YJAT sustained release tabletTest drug: Tramadol HCI/Acetaminophen 75/650mg, two times daily. Reference drug: Tramadol HCI/Acetaminophen 37.5/325 mg, four times daily. | Drug | Group A, Group B |
Primary outcome
Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state
Time frame: 0 to 36 hour
Bio-equivalence of Cmax at steady state of tramadol and acetaminophen
Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state
Time frame: 0 to 36 hour
Bio-equivalence of AUC at steady state of tramadol and acetaminophen
7 secondary outcomes
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
Time frame: 0 to 36 hour
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
Time frame: 0 to 36 hour
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
Time frame: 0 to 36 hour
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
Time frame: 0 to 36 hour
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
Time frame: 0 to 36 hour
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
Time frame: 0 to 36 hour
Evaluate the pharmacokinetics profiles of tramadol, acetaminophen and O-desmethyltramadol at steady state
Time frame: 0 to 36 hour
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 5 May 2021.
- Derived from this study: PubMed 25618318Im YJ, Jeon JY, Kim EY, Kim Y, Oh DJ, Yoo JS, Shin DH, Chae SW, Kim MG. An assessment of the pharmacokinetics of a sustained-release formulation of a tramadol/acetaminophen combination in healthy subjects. Clin Ther. 2015 Feb 1;37(2):376-89. doi: 10.1016/j.clinthera.2014.12.007. Epub 2015 Jan 22.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tramadol HCI/Acetaminophen in people with Pain, run by Yungjin Pharm. Co., Ltd..
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 3 inclusion and 5 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 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluate the pharmacokinetic profiles of tramadol and acetaminophen at steady state (time frame: 0 to 36 hour). 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 NCT01880125, 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 5 May 2021.