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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

Information source: Labopharm Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl) (Drug); DDS-06C (650 mg acetaminophen and 75 mg tramadol) (Drug); Zaldiar® (Drug); Ultracet® (Drug); Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditions (Drug); Zaldiar®, multiple doses,(fed & fasting): (Drug); Ultracet®, multiple doses, (fed & fasting) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Labopharm Inc.

Official(s) and/or principal investigator(s):
Darren Wilbraham, Principal Investigator, Affiliation: Guy's Drug Research Unit, Quintiles Ltd

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Rate and extent of exposure

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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

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

Starting date: May 2008
Last updated: April 24, 2012

Page last updated: August 23, 2015

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