HealthyPhase 1NCT01778075
A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition
A Phase 1 study testing Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER) and Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER) in people with Healthy, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the bioequivalence of a newly developed ULTRACET extended-release (ER) tablet of tramadol hydrochloride and acetaminophen, to the current marketed ULTRACET ER tablet, in healthy participants under fasted condition. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men only
- Conditions the study is for
- Healthy
- What is being tested?
- Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER) and Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Feb 2013
- 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate
- Must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Body mass index (weight [kg]/height2 [m]2) between 18.5 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac function, including sinus rhythm, pulse rate between 45 and 90 bpm, QTc interval <= 450 ms, QRS interval of <110 ms, PR interval <200 ms, and morphology consistent with healthy cardiac function
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic (blood) disease, coagulation disorders (including any abnormal bleeding), lipid abnormalities, significant lung disease (including bronchospastic respiratory disease), diabetes mellitus, kidney or liver insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening (or at admission to the study center) as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for oral contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
- History of, or reason to believe a participant has a history of, drug or alcohol abuse within the past 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose, Open-Label, Randomized, Two-Way Crossover Pivotal Study to Assess the Bioequivalence of a New ULTRACET ER Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition
The purpose of this study is to evaluate the bioequivalence of a newly developed ULTRACET extended-release (ER) tablet of tramadol hydrochloride and acetaminophen, to the current marketed ULTRACET ER tablet, in healthy participants under fasted condition.
- Conditions
- Healthy
- Being tested
- Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER), Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)
- Keywords
- Healthy, Ultracet extended release (ER), Tramadol hydrochloride, Acetaminophen, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER)Drug
Single oral dose of newly developed ULTRACET ER, (Tramadol HCl/Acetaminophen 75/650 mg), administered under fasted condition.
Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)Drug
Single oral dose of marketed ULTRACET ER, (Tramadol HCl/Acetaminophen 75/650 mg), administered under fasted condition.
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence AB | Experimental | Treatment A: Newly developed Ultracet ER; Treatment B: Marketed Ultracet ER Receives: Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER); Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER) |
| Treatment sequence BA | Experimental | Treatment A: Newly developed Ultracet ER; Treatment B: Marketed Ultracet ER Receives: Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER); Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of racemic tramadol (Period 1)
Measured: Up to 48 hours following the administration of study drug on Day 1 of Period 1
Plasma concentrations of acetaminophen (Period 1)
Measured: Up to 48 hours following the administration of study drug on Day 1 of Period 1
Plasma concentrations of racemic tradamdol (Period 2)
Measured: Up to 48 hours following the administration of study drug on Day 1 of Period 2
Plasma concentrations of acetaminophen (Period 2)
Measured: Up to 48 hours following the administration of study drug on Day 1 of Period 2
Secondary outcomes (1)
Incidence of adverse events as a measure of safety and tolerability
Measured: Approximately 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778075
- Sponsor's protocol ID
- CR100924
- Other IDs
- TRAMCTPAI1003
- Status last verified
- Feb 2014
- First submitted
- 25 Jan 2013
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Open-Label, Randomized, Two-Way Crossover Pivotal Study to Assess the Bioequivalence of a New ULTRACET ER Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition
- ClinicalTrials.gov ID
- NCT01778075
- Acronym / sponsor ID
- CR100924
- Conditions
- Healthy
- Keywords
- Healthy, Ultracet extended release (ER), Tramadol hydrochloride, Acetaminophen, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 29 Jan 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.
The purpose of this study is to evaluate the bioequivalence of a newly developed ULTRACET extended-release (ER) tablet of tramadol hydrochloride and acetaminophen, to the current marketed ULTRACET ER tablet, in healthy participants under fasted condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence AB | Experimental | Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER), Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)Treatment A: Newly developed Ultracet ER; Treatment B: Marketed Ultracet ER |
| Treatment sequence BA | Experimental | Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER), Drug: Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)Treatment A: Newly developed Ultracet ER; Treatment B: Marketed Ultracet ER |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate
- Must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Body mass index (weight [kg]/height2 [m]2) between 18.5 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac function, including sinus rhythm, pulse rate between 45 and 90 bpm, QTc interval <= 450 ms, QRS interval of <110 ms, PR interval <200 ms, and morphology consistent with healthy cardiac function
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic (blood) disease, coagulation disorders (including any abnormal bleeding), lipid abnormalities, significant lung disease (including bronchospastic respiratory disease), diabetes mellitus, kidney or liver insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening (or at admission to the study center) as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for oral contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
- History of, or reason to believe a participant has a history of, drug or alcohol abuse within the past 5 years
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 HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER)Single oral dose of newly developed ULTRACET ER, (Tramadol HCl/Acetaminophen 75/650 mg), administered under fasted condition. | Drug | Treatment sequence AB, Treatment sequence BA |
| Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)Single oral dose of marketed ULTRACET ER, (Tramadol HCl/Acetaminophen 75/650 mg), administered under fasted condition. | Drug | Treatment sequence AB, Treatment sequence BA |
Primary outcome
Plasma concentrations of racemic tramadol (Period 1)
Time frame: Up to 48 hours following the administration of study drug on Day 1 of Period 1
Plasma concentrations of acetaminophen (Period 1)
Time frame: Up to 48 hours following the administration of study drug on Day 1 of Period 1
Plasma concentrations of racemic tradamdol (Period 2)
Time frame: Up to 48 hours following the administration of study drug on Day 1 of Period 2
Plasma concentrations of acetaminophen (Period 2)
Time frame: Up to 48 hours following the administration of study drug on Day 1 of Period 2
1 secondary outcome
Incidence of adverse events as a measure of safety and tolerability
Time frame: Approximately 5 weeks
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 10 Feb 2014.
- A Single-Dose, Open-Label, Randomized, Two-Way Crossover Pivotal Study to Assess the Bioequivalence of a New ULTRACET ER Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted ConditionsLink provided by the sponsor.
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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.
Janssen Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
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 Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER) and Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER) in people with Healthy, run by Janssen Korea, Ltd., Korea 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 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 10 Feb 2014. 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?
Plasma concentrations of racemic tramadol (Period 1) (time frame: Up to 48 hours following the administration of study drug on Day 1 of Period 1). 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 10 Feb 2014.