CompletedNCT00973232Updated Apr 25, 2012

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 interventional study of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl) and DDS-06C (650 mg acetaminophen and 75 mg tramadol) in Healthy, sponsored by Labopharm Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-25.

Sponsored by Labopharm Inc. · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Enrollment: 58
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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 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 studied

Healthy

Keywords

Tramadol
Acetaminophen
combination
pharmacokinetics
bioavailability
Zaldiar
Ultracet
fed
fasted
single-dose
multiple-dose
healthy
volunteers
Healthy volunteers

In context

Lead sponsor

Labopharm Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 1
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 58 participants (actual)

Study arms

Experimental
Part A, Arm A
Drug: DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl)
Experimental
Part A, Arm B
Drug: DDS-06C (650 mg acetaminophen and 75 mg tramadol)
Active comparator
Part A, Arm C
Drug: Zaldiar®
Active comparator
Part A, Arm D
Drug: Ultracet®
Experimental
Part B, Arm E
Drug: Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditions
Active comparator
Part B, Arm F
Drug: Zaldiar®, multiple doses,(fed & fasting):
Active comparator
Part B, Arm G
Drug: Ultracet®, multiple doses, (fed & fasting)

Interventions

DrugDDS-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
DrugDDS-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
DrugZaldiar®
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)
DrugUltracet®
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)
DrugTwo tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditions
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
DrugZaldiar®, 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
DrugUltracet®, 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

What researchers measure

Primary outcomes

Rate and extent of exposure
Time frame: 0 to 36 hours post dose

Study locations

1 site

Guy's Drug Research Unit, Quintiles Ltd
London, SE1 1YR, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00973232
Lead sponsor: Labopharm Inc.
Responsible party: Sponsor
First posted: Sep 9, 2009
Start date: May 2008
Primary completion: Aug 2008
Completion: Aug 2008
Last update: Apr 25, 2012

Study contacts

Darren Wilbraham

principal investigator · Guy's Drug Research Unit, Quintiles Ltd

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Labopharm Inc.

Start the discussion