---
title: Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol
nct_id: NCT01214941
overall_status: COMPLETED
phase: PHASE4
sponsor: Turku University Hospital
study_type: INTERVENTIONAL
primary_condition: Pharmacokinetics
countries: Finland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01214941.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01214941"
ct_last_update_post_date: 2011-04-13
last_seen_at: "2026-05-12T06:20:45.814Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol

**NCT ID:** [NCT01214941](https://clinicaltrials.gov/study/NCT01214941)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 12
- **Lead Sponsor:** Turku University Hospital
- **Conditions:** Pharmacokinetics, Pharmacodynamics
- **Start Date:** 2010-09
- **Completion Date:** 2010-12
- **CT.gov Last Update:** 2011-04-13

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 40 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Placebo** (PLACEBO_COMPARATOR)
- **Ticlopidine** (ACTIVE_COMPARATOR)
- **Ticlopidine and itraconazole** (ACTIVE_COMPARATOR)

## Interventions

- **Placebo** (DRUG) — The subjects will be given orally placebo twice a day for 5 days prior to the study.
- **Ticlopidine** (DRUG) — The subjects will be given orally ticlopidine 250mg twice a day for 5 days prior to the study.
- **Ticlopidine and itraconazole** (DRUG) — The subjects will be given orally ticlopidine 250mg twice a day and itraconazole 200mg as a single daily dose for 5 days prior to the study.

## Primary Outcomes

- **Concentration of tramadol and its metabolites in plasma** _(time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours after administration of tramadol)_

## Secondary Outcomes

- **Metabolites of tramadol in urine** _(time frame: 0-12 and 12-24 hour fractions after administration of tramadol)_
- **Serotonin concentrations** _(time frame: 0, 4 and 8 hours after tramadol administration)_
- **Pharmacodynamic effects** _(time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12 hours after administration of tramadol)_
- **Analgesia** _(time frame: 1, 2, 3, 4, 5, 6, 8, 10, 12 hours after the administration of tramadol)_

## Locations (1)

- Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University and Turku University Hospital, Turku, Finland

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of anaesthesiology, intensive care, emergency care and pain medicine, turku university and turku university hospital|turku||finland` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01214941*  
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