A Dose Linearity Study of the Labopharm Formulation of Tramadol HCl/Contramid®, 100 mg, 200 mg and 300 mg After A Single Oral Administration In Fasting Condition, In Healthy Human Volunteers

NCT00834808 | Completed Phase 1 Results

• 1 other identifier: MDT1-011
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purposes of this study were:

• To evaluate the plasma pharmacokinetic profile of tramadol and its principal metabolite, the O-desmethyltramadol, after a single oral administration of 100, 200 and 300 mg of tramadol as the Labopharm extended-release formulation prepared with Contramid.
• To assess the dose linearity of tramadol and its principal metabolite, the O-desmethyltramadol, between 100 mg and 300 mg following a single dose administration of the Labopharm extended-release formulation prepared with Contramid under fasting conditions in young healthy volunteers.

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (3)

• AUC(0-t)

  Area under the plasma concentration versus time curve to the last measurable concentration. h = hours

  48 hours

• AUC(0-inf)

  Area under the plasma concentration versus time curve extrapolated to infinity. h = hours

  48 hours

• Cmax

  Maximum plasma concentration.

  48 hours

Secondary Outcomes (2)

• Tmax

  48 hours

• t1/2

  48 hours

Study Arms (3)

1: Tramadol HCl 100mg

EXPERIMENTAL

Drug: Tramadol HCl

2: Tramadol HCl 200mg

EXPERIMENTAL

Drug: Tramadol HCl

3: Tramadol HCl 300mg

EXPERIMENTAL

Drug: Tramadol HCl

Interventions

Tramadol HCl DRUG

One single oral administration of Tramadol HCl 100 mg, 200 mg or 300 mg as per randomization schedule.

1: Tramadol HCl 100mg; 2: Tramadol HCl 200mg; 3: Tramadol HCl 300mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject.
• Males aged from 18 to 45 years inclusively and with Body Mass Index (BMI) between 18 and 30 kg/m2 inclusively.
• Clinical laboratory values within 10% above or below the laboratory's stated normal range; if not within this range, the clinical investigator will decide if they were not clinically significant and recorded this fact on the Case Report Form (CRF).
• Healthy according to the physical examination and laboratory results.
• Normal cardiovascular function according to a 12-lead electrocardiogram (ECG).
• Non-smoker or subjects smoking no more than 5 cigarettes per day (or equivalent) and able to abstain from smoking during inpatient phases of the study.
• Subjects covered by Social Security in compliance with the recommendations of French Law relating to biomedical research.
• Subjects with normal dietary requirements (neither vegetarian, nor on a diet).

You may not qualify if:

• History of hypersensitivity to tramadol or any other compounds.
• Presence or significant history of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs.
• Presence or significant history of cardiovascular, pulmonary, haematological, neoplasic, neurological, psychiatric, endocrine, immunological or dermatological disease.
• Presence or significant history of glaucoma.
• Supine pulse rate lower than 45 beats per minute (bpm) after 5 minutes at rest or higher than 100 bpm.
• History of hypotensive episodes or a standing systolic blood pressure reading of \<100 mmHg or a diastolic reading of \<45 mmHg, measured on the screening day.
• History of hypertensive episodes or a supine systolic blood pressure reading of \>145 mmHg or a diastolic reading of \>95 mmHg, measured on the screening day.
• Presence of atrioventricular (AV) block assessed during pre-study evaluation or during the study. The lower limit considered for a first degree AV block was be a PR interval of 200 millisecond (msec).
• Maintenance therapy with any drug, or history of drug dependency, alcohol abuse (\>3 units of alcohol per day), or serious psychological disease.
• Subjects consuming large quantities of drinks containing xanthine bases (coffee, tea, chocolate or cola; more than 6 cups or glasses per day).
• Any clinically significant illness in the previous 21 days before day 1 of this study.
• Subjects who had undergone general anesthesia within 3 months prior to the present study.
• Use of drugs known to affect liver enzymes (eg, inducers or inhibitors of Cytochrome P450) in the previous 30 days before day 1 of this study (eg, all barbiturates, corticosteroids, di \& methyl-phenylhydantoin).
• Use of any medication (including OTC preparations) in the previous 14 days before day 1 of this study.
• Donation of 350 mL (or more) of blood in the previous 3 months or participation in another clinical trial in the previous 3 months before day 1 of this study.

Sponsors & Collaborators

• Labopharm Inc.: lead

Related Publications (1)

• Karhu D, El-Jammal A, Dupain T, Gaulin D, Bouchard S. Pharmacokinetics and dose proportionality of three Tramadol Contramid OAD tablet strengths. Biopharm Drug Dispos. 2007 Sep;28(6):323-30. doi: 10.1002/bdd.561.

  PMID: 17575561 RESULT

Related Links

• Approved labelling

MeSH Terms

Interventions

Tramadol

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Labopharm Inc.

1 450 686 1017

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 3, 2009
• Study Start: November 1, 2002
• Primary Completion: December 1, 2002
• Study Completion: December 1, 2002
• Last Updated: April 27, 2012
• Results First Posted: June 2, 2009

Record last verified: 2012-04