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

NCT00973232 | Completed Phase 1

• 1 other identifier: 06CCL102
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate and extent of exposure

  0 to 36 hours post dose

Study Arms (7)

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)

Interventions

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

Part A, Arm A

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

Part A, Arm B

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)

Part A, Arm C

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)

Part A, Arm D

Two tablets of DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), multiple doses, under both fed and fasting conditions DRUG

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 E

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

Part B, Arm F

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

Part B, Arm G

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Labopharm Inc.: lead

Study Sites (1)

Guy's Drug Research Unit, Quintiles Ltd

London, SE1 1YR, United Kingdom

Location

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency

Interventions

Acetaminophen; Tramadol; Ultracet

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Officials

• Darren Wilbraham

  Guy's Drug Research Unit, Quintiles Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 9, 2009
• Study Start: May 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 25, 2012

Record last verified: 2012-04

Locations

GB (1)