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
NCT ID: NCT00973232
Last Updated: 2012-04-25
Study Results
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Basic Information
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COMPLETED
PHASE1
58 participants
INTERVENTIONAL
2008-05-31
2008-08-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Part A, Arm A
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
Part A, Arm B
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
Part A, Arm C
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)
Part A, Arm D
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)
Part B, Arm E
Two 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
Part B, Arm F
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
Part B, Arm G
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
Interventions
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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
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
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)
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)
Two 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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Labopharm Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Darren Wilbraham
Role: PRINCIPAL_INVESTIGATOR
Guy's Drug Research Unit, Quintiles Ltd
Locations
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Guy's Drug Research Unit, Quintiles Ltd
London, , United Kingdom
Countries
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Other Identifiers
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06CCL102
Identifier Type: -
Identifier Source: org_study_id
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