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CompletedNCT00470041Updated Jun 16, 2010

Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers

A Phase 1 interventional study of administration of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation in Healthy, sponsored by University Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-06-16.

Sponsored by University Ghent · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study summary

Description: To investigate bioavailability of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation (trial formulation) especially designed for pediatric use.

Interventions: 12 healthy volunteers will receive in a cross-over design two formulations i.e. the commercially available tablet formulation and the trial formulation. Blood samples (13 over 24 h) will be taken in order to determine the pharmacokinetic profile of the drugs from both formulations and will be compared.

Duration of intervention: 2 days + 7 days of wash-out between both oral administrations.

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Conditions studied

  • Healthy

Keywords

  • Healthy volunteers
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In context

Lead sponsor

University Ghent is the lead sponsor of 345 studies on the registry; 85 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged between 18 and 55 years, extremes included. Males and females.
  • Smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day (or non-smoking) for at least 3 months prior to selection.
  • Normal weight as defined by a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
  • Subject is competent and willing to sign informed consent form after being given all the detailed information about the study. Informed consent form signed voluntarily.
  • Healthy on the basis of a pre-trial physical examination, medical history, electrocardiogram and the results of blood biochemistry and haematology tests and a urinalysis carried out less than 3 weeks before the first dose.

Exclusion criteria

Exclusion Criteria:

  • Subjects presenting anaemia, neutropenia or platelets deficits
  • Subjects with kidney failure or renal dysfunction
  • Pregnant, lactating females
  • History of allergy or hypersensitivity to Zidovudine or Lamivudine.
  • History of clinically cardiovascular disease or liver disorder
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Interventions

  • Drugadministration of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation
06

What researchers measure

Primary outcomes

  1. bioavailability of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation (trial formulation) especially designed for pediatric use

    Time frame: over 24 hours

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00470041
Lead sponsor
University Ghent
First posted
May 7, 2007
Start date
Jun 2007
Primary completion
Oct 2009
Completion
Dec 2009
Last update
Jun 16, 2010

Study contacts

Luc Van Bortel, MD, PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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