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Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol

Information source: Turku University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics; Pharmacodynamics

Intervention: Placebo (Drug); Ticlopidine (Drug); Ticlopidine and itraconazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Turku University Hospital

Official(s) and/or principal investigator(s):
Klaus T Olkkola, MD, PhD, Prof, Principal Investigator, Affiliation: Turku University Hospital and Turku University

Summary

Tramadol is an opioid analgesic, which is widely used in the treatment of acute and neuropathic pain. After oral administration, tramadol is rapidly and almost completely absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation is catalysed by CYP2D6. The formation of inactive metabolites is catalysed by CYP3A4 and 2B6. This study is aimed to investigate the possible interaction of oral tramadol with itraconazole and ticlopidine, which are inhibitors of CYP3A4 and 2B6. Twelve healthy male or female adult non-smoking volunteers aged 18-40 years with body weights within 15% of the ideal weight for height are taken into the study. Primary endpoints of the study are plasma concentrations of tramadol and its metabolites.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Primary outcome: Concentration of tramadol and its metabolites in plasma

Secondary outcome:

Metabolites of tramadol in urine

Serotonin concentrations

Pharmacodynamic effects

Analgesia

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy volunteers

- Age 18-40

- Body weight within ±15% of the ideal weight for height

Exclusion Criteria:

- A previous history of intolerance to the study drugs or to related compounds and

additives

- Concomitant drug therapy of any kind for at least 14 days prior to the study

- Existing or recent significant disease

- History of hematological, endocrine, metabolic or gastrointestinal disease, including

gut motility disorders

- History of asthma or any kind of drug allergy

- Previous or present alcoholism, drug abuse, psychological or other emotional problems

that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements

- A positive test result for urine toxicology

- A "yes" answer to any one of the Abuse Questions

- Pregnancy or nursing

- Donation of blood for 4 weeks prior and during the study

- Special diet or life style conditions which would compromise the conditions of the

study or interpretation of the results

- Participation in any other studies involving investigational or marketed drug

products concomitantly or within one month prior to the entry into this study

- Smoking for one month before the start of the study and during the whole study period

- Any history of coagulation abnormality, also in first degree relatives

Locations and Contacts

Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University and Turku University Hospital, Turku 20521, Finland
Additional Information

Starting date: September 2010
Last updated: April 12, 2011

Page last updated: August 23, 2015

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