NCT00695071

Brief Summary

The objective of this clinical trial is to document the steady state pharmacokinetics and safety of a new itraconazole 200 mg film coated tablet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

September 26, 2011

Status Verified

September 1, 2011

Enrollment Period

1 month

First QC Date

June 9, 2008

Last Update Submit

September 23, 2011

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Steady State Plasma levels of Itraconazole

    2 weeks

Study Arms (1)

A

ACTIVE COMPARATOR
Drug: Itraconazole

Interventions

ItraconazoleDRUG

Oral

A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18.0 and 28.0 kg/m2
  • Good physical and mental health status, determined on the basis of the medical history and a general clinical examination.
  • Vital signs (blood pressure and heart rate) in supine position within the normal range
  • Electrocardiogram (12 lead) considered as normal
  • Non-smoker.
  • Able to swallow pills
  • If subject is a woman of childbearing potential (WOCBP), must agree to use adequate birth control as defined by the protocol

You may not qualify if:

  • Any disease or physical condition which, in the opinion of the investigator, could impact the pharmacokinetics of the drug
  • History or presence of drug abuse or consumption of alcohol
  • History of sensitivity or allergy to azoles or related drugs
  • Any requirement to be on other drug treatment (except acetaminophen and for WOCBP, hormonal contraceptives)
  • Unsuitable veins for repeated venipuncture.
  • Clinically significant abnormal ECG
  • Nursing mothers and pregnant women, or women of childbearing potential not using adequate contraceptives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advanced Biomedical Research

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 11, 2008

Study Start

June 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

September 26, 2011

Record last verified: 2011-09

Locations

US(1)