To Determine Bioequivalence Under Fasting ConditionsPhase 1NCT00653315
Bioavailability Study of Tramadol/APAP Tablets Under Fasting Conditions
A Phase 1 study testing Tramadol APAP and Ultracet in people with To Determine Bioequivalence Under Fasting Conditions, run by Par Pharmaceutical, Inc..
Trial summary
To compare the relative bioavailability of Kali and Ortho-McNeil's Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- To Determine Bioequivalence Under Fasting Conditions
- What is being tested?
- Tramadol APAP and Ultracet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Aug 2002
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Males and females between 18 and 45 years of age inclusive
- Informed of the nature of the study and given written informed consent.
- Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100lbs.
Who cannot join
- Hypersensitivity to Tramadol/ Acetaminophen, opioids such as morphine and codeine, or related compounds, or a history or seizures.
- Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
- Recent history (within one year) of mental illness, drug illness, drug abuse or alcoholism.
- Donation of greater than 500mL of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
- Received an investigational drug within the 4 weeks prior to study dosing.
- Currently taking any prescription medication, except oral contraceptives, within 7days prior to study dosing or over-the-counter medication within 3 days of the study dosing.
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- This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the physician.
- Tobacco use(>5 cigarettes per day)in the 3 months prior to study dosing.
- If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods.
- Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed.
- Medically acceptable methods of contraception that may be used by the subject and/or her partner are:oral contraceptive, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence.
- females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
About this study
Official title: To Compare the Relative Bioavailability of the Kali's Tramadol APAP Tablets With Ortho-McNeil's Ultracet Tablets Under Fasting Conditions.
To compare the relative bioavailability of Kali and Ortho-McNeil's
Read the detailed description
To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with Ortho-McNeil's Ultracet tablets 37.5mg/325mg
- Being tested
- Tramadol APAP, Ultracet
- Keywords
- Bioequivalence, Tramadol APAP, fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol APAPDrug
Also called Ultracet
Tablets, 37.5mg/325mg, single dose
UltracetDrug
Also called Tramadol APAP
Tablets, 37.5mg/325mg
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects received kali product under fasting conditions Receives: Drug: Tramadol APAP |
| B | Active comparator | Subjects received Ortho-Mcneil product under fasting conditions Receives: Drug: Ultracet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of absorption
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startMay 2002
- Primary completionAug 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine Bioequivalence Under Fasting ConditionsStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AAI Clinic
- Investigators
- Ralph Scallion, Principal investigator, AAI Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653315
- Sponsor's protocol ID
- AAI-US-121
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 11 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Relative Bioavailability of the Kali's Tramadol APAP Tablets With Ortho-McNeil's Ultracet Tablets Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT00653315
- Acronym / sponsor ID
- AAI-US-121
- Keywords
- Bioequivalence, Tramadol APAP, fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AAI Clinic
- Study start
- May 2002
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 4 Apr 2008 (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.
To compare the relative bioavailability of Kali and Ortho-McNeil's
Detailed description
To compare the relative bioavailability of Kali's Tramadol/APAP 37.5mg/325mg with Ortho-McNeil's Ultracet tablets 37.5mg/325mg
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Tramadol APAPSubjects received kali product under fasting conditions |
| B | Active comparator | Drug: UltracetSubjects received Ortho-Mcneil product under fasting conditions |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Males and females between 18 and 45 years of age inclusive
- Informed of the nature of the study and given written informed consent.
- Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100lbs.
Key exclusion criteria (12 listed)
- Hypersensitivity to Tramadol/ Acetaminophen, opioids such as morphine and codeine, or related compounds, or a history or seizures.
- Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
- Recent history (within one year) of mental illness, drug illness, drug abuse or alcoholism.
- Donation of greater than 500mL of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
- Received an investigational drug within the 4 weeks prior to study dosing.
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 APAPAlso: UltracetTablets, 37.5mg/325mg, single dose | Drug | A |
| UltracetAlso: Tramadol APAPTablets, 37.5mg/325mg | Drug | B |
Primary outcome
Rate and Extend of absorption
Time frame: 24 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 11 Apr 2008.
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.
Ralph Scallion principal investigator
AAI Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tramadol APAP and Ultracet in people with To Determine Bioequivalence Under Fasting Conditions, run by Par Pharmaceutical, Inc..
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 12 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 11 Apr 2008. 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?
Rate and Extend of absorption (time frame: 24 Hours). 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 11 Apr 2008.