Healthy
Conditions
Keywords
Tramadol, Acetaminophen, combination, pharmacokinetics, bioavailability, Zaldiar, Ultracet, fed, fasted, single-dose, multiple-dose, healthy, volunteers, Healthy volunteers
Brief 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.
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.
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
Sponsors
Labopharm Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate and extent of exposure | 0 to 36 hours post dose |
Countries
United Kingdom
Outcome results
None listed