HealthyPhase 1NCT00973232
A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers
A Phase 1 study testing DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), DDS-06C (650 mg acetaminophen and 75 mg tramadol) and Zaldiar® in people with Healthy, run by Labopharm Inc. at 1 site in United Kingdom.
Trial summary
The objectives of this two-part study were to compare the single-dose and multiple-dose pharmacokinetics of extended release and immediate-release fixed combination formulations containing tramadol-HCl/acetaminophen and to evaluate the effect of food on the extended-release formulation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), DDS-06C (650 mg acetaminophen and 75 mg tramadol) and Zaldiar®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2008to Aug 2008
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males or females aged 18-55 years inclusive with body mass index (BMI) between 18-30 kg/m2
- Healthy as determined by pre-study medical history, physical examination and 12-lead ECG
- Clinical laboratory tests within the reference ranges or clinically acceptable to the Investigator
- Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening
- Negative for drugs of abuse and alcohol at screening and admission
- Non-smokers for at least 3 months preceding screening
- If female, were not currently pregnant or breast feeding and were using medically acceptable methods of contraception and if male, were themselves and their female partners using medically acceptable methods of contraception
- Able and willing to give written informed consent.
Who cannot join
- Subjects who did not conform to the above inclusion criteria
- Female subjects who were pregnant, trying to become pregnant, lactating or not using acceptable methods of contraception
- Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
- Clinically relevant surgical history
- Clinically relevant family history
- History of relevant atopy
Show all 20Show fewer
- History of relevant drug hypersensitivity
- History of alcoholism
- History of drug abuse
- Male subjects who consumed more than 21 units of alcohol a week and female subjects who consumed more than 14 units of alcohol a week
- Significant infection or known inflammatory process on screening
- Acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn)
- Acute infection such as influenza at the time of screening or admission
- Use of prescription drugs within 7 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor
- Use of over-the-counter medication excluding routine vitamins but including mega dose vitamin therapy within 14 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor
- Use of any investigational drug or participation in any clinical trial within 3 months of their first dosing
- Donation or receipt of any blood or blood products within the previous 3 months prior to first dosing
- Vegetarians, vegans or having medical or cultural dietary restrictions.
- Inability to communicate reliably with the Investigator.
- Subjects who were unlikely to co-operate with the requirements of the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's Drug Research Unit, Quintiles Ltd
London, SE1 1YR
About this study
Official title: A Single-Centre, Open-Label, Randomised Study to Compare the Single Dose (Including the Effect of Food) and Multiple Dose Pharmacokinetic Profiles of Acetram Contramid® BID Tablets vs the Immediate-Release Tablet Reference Products Zaldiar® and Ultracet®
The objectives of this two-part study were to compare the single-dose and multiple-dose pharmacokinetics of extended release and immediate-release fixed combination formulations containing tramadol-HCl/acetaminophen and to evaluate the effect of food on the extended-release formulation.
Read the detailed description
- To compare the single (Part A) and multiple dose (Part B) pharmacokinetic profiles and bioavailability of DDS-06C tablets with the immediate-release tablet reference products Zaldiar® and Ultracet®.
- To assess the effect of food on the pharmacokinetic profile of DDS-06C tablets following administration of a single oral dose.
- To monitor and record all adverse events.
- Conditions
- Healthy
- Being tested
- DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), DDS-06C (650 mg acetaminophen and 75 mg tramadol), Zaldiar®, Ultracet®, Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditions
- Keywords
- Tramadol, Acetaminophen, combination, pharmacokinetics, bioavailability, Zaldiar, Ultracet, fed, fasted, single-dose, multiple-dose, healthy, volunteers, Healthy volunteers
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl)Drug
DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl: two tablets, single dose, total administered of 1300 mg acetaminophen/150 mg tramadol HCl under fasting conditions
DDS-06C (650 mg acetaminophen and 75 mg tramadol)Drug
DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl: two tablets, single dose, total administered of 1300 mg acetaminophen/150 mg tramadol HCl under fed conditions
Zaldiar®Drug
Zaldiar® (325 mg acetaminophen and 37.5 mg tramadol HCl): two tablets; dose of 650 mg acetaminophen/75 mg tramadol HCl administered at Time = 0 hr (fasting)and second dose at Time = 6 hr (fed) Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl)
Ultracet®Drug
Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl)two tablets; dose of 650 mg acetaminophen/75 mg tramadol HCl administered at Time = 0 hr (fasting)and second dose at Time = 6 hr (fed) Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl)
Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditionsDrug
Two tablets of DDS-06C, twice daily at 12-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl
Zaldiar®, multiple doses,(fed & fasting):Drug
Two tablets of Zaldiar®, 4 times daily at 6-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl
Ultracet®, multiple doses, (fed & fasting)Drug
Two tablets of Ultracet®, 4 times daily at 6-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl
| Study group | Role | What they receive |
|---|---|---|
| Part A, Arm A | Experimental | Not described Receives: Drug: DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl) |
| Part A, Arm B | Experimental | Not described Receives: Drug: DDS-06C (650 mg acetaminophen and 75 mg tramadol) |
| Part A, Arm C | Active comparator | Not described Receives: Drug: Zaldiar® |
| Part A, Arm D | Active comparator | Not described Receives: Drug: Ultracet® |
| Part B, Arm E | Experimental | Not described Receives: Drug: Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditions |
| Part B, Arm F | Active comparator | Not described Receives: Drug: Zaldiar®, multiple doses,(fed & fasting): |
| Part B, Arm G | Active comparator | Not described Receives: Drug: Ultracet®, multiple doses, (fed & fasting) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and extent of exposure
Measured: 0 to 36 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startMay 2008
- Primary completionAug 2008
- Study completionAug 2008
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Labopharm Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darren Wilbraham, Principal investigator, Guy's Drug Research Unit, Quintiles Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973232
- Sponsor's protocol ID
- 06CCL102
- Status last verified
- Apr 2012
- First submitted
- 8 Sep 2009
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Open-Label, Randomised Study to Compare the Single Dose (Including the Effect of Food) and Multiple Dose Pharmacokinetic Profiles of Acetram Contramid® BID Tablets vs the Immediate-Release Tablet Reference Products Zaldiar® and Ultracet®
- ClinicalTrials.gov ID
- NCT00973232
- Acronym / sponsor ID
- 06CCL102
- Conditions
- Healthy
- Keywords
- Tramadol, Acetaminophen, combination, pharmacokinetics, bioavailability, Zaldiar, Ultracet, fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Labopharm Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 9 Sep 2009 (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 objectives of this two-part study were to compare the single-dose and multiple-dose pharmacokinetics of extended release and immediate-release fixed combination formulations containing tramadol-HCl/acetaminophen and to evaluate the effect of food on the extended-release formulation.
Detailed description
- To compare the single (Part A) and multiple dose (Part B) pharmacokinetic profiles and bioavailability of DDS-06C tablets with the immediate-release tablet reference products Zaldiar® and Ultracet®.
- To assess the effect of food on the pharmacokinetic profile of DDS-06C tablets following administration of a single oral dose.
- To monitor and record all adverse events.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A, Arm A | Experimental | Drug: DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl) |
| Part A, Arm B | Experimental | Drug: DDS-06C (650 mg acetaminophen and 75 mg tramadol) |
| Part A, Arm C | Active comparator | Drug: Zaldiar® |
| Part A, Arm D | Active comparator | Drug: Ultracet® |
| Part B, Arm E | Experimental | Drug: Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditions |
| Part B, Arm F | Active comparator | Drug: Zaldiar®, multiple doses,(fed & fasting): |
| Part B, Arm G | Active comparator | Drug: Ultracet®, multiple doses, (fed & fasting) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adult males or females aged 18-55 years inclusive with body mass index (BMI) between 18-30 kg/m2
- Healthy as determined by pre-study medical history, physical examination and 12-lead ECG
- Clinical laboratory tests within the reference ranges or clinically acceptable to the Investigator
- Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening
- Negative for drugs of abuse and alcohol at screening and admission
Key exclusion criteria (20 listed)
- Subjects who did not conform to the above inclusion criteria
- Female subjects who were pregnant, trying to become pregnant, lactating or not using acceptable methods of contraception
- Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
- Clinically relevant surgical history
- Clinically relevant family history
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 |
|---|---|---|
| DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl)DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl: two tablets, single dose, total administered of 1300 mg acetaminophen/150 mg tramadol HCl under fasting conditions | Drug | Part A, Arm A |
| DDS-06C (650 mg acetaminophen and 75 mg tramadol)DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl: two tablets, single dose, total administered of 1300 mg acetaminophen/150 mg tramadol HCl under fed conditions | Drug | Part A, Arm B |
| Zaldiar®Zaldiar® (325 mg acetaminophen and 37.5 mg tramadol HCl): two tablets; dose of 650 mg acetaminophen/75 mg tramadol HCl administered at Time = 0 hr (fasting)and second dose at Time = 6 hr (fed) Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl) | Drug | Part A, Arm C |
| Ultracet®Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl)two tablets; dose of 650 mg acetaminophen/75 mg tramadol HCl administered at Time = 0 hr (fasting)and second dose at Time = 6 hr (fed) Ultracet® (325 mg acetaminophen and 37.5 mg tramadol HCl) | Drug | Part A, Arm D |
| Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditionsTwo tablets of DDS-06C, twice daily at 12-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl | Drug | Part B, Arm E |
| Zaldiar®, multiple doses,(fed & fasting):Two tablets of Zaldiar®, 4 times daily at 6-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl | Drug | Part B, Arm F |
| Ultracet®, multiple doses, (fed & fasting)Two tablets of Ultracet®, 4 times daily at 6-hour intervals under fed conditions for the first 4 days, then under fasting conditions for the 5th day. The total daily dose administered was 2600 mg Acetaminophen/300 mg tramadol HCl | Drug | Part B, Arm G |
Primary outcome
Rate and extent of exposure
Time frame: 0 to 36 hours post dose
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 25 Apr 2012.
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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.
Darren Wilbraham principal investigator
Guy's Drug Research Unit, Quintiles Ltd
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 DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), DDS-06C (650 mg acetaminophen and 75 mg tramadol) and Zaldiar® in people with Healthy, run by Labopharm Inc. at 1 site in United Kingdom.
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 8 inclusion and 20 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 25 Apr 2012. 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 United Kingdom. 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?
Rate and extent of exposure (time frame: 0 to 36 hours post dose). 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 25 Apr 2012.