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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00470041
First Posted: May 7, 2007
Last Update Posted: June 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Ghent
  Purpose

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.


Condition Intervention Phase
Healthy Drug: administration of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470041


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Investigators
Principal Investigator: Luc Van Bortel, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: Prof. Dr. Luc Van Bortel, University Ghent
ClinicalTrials.gov Identifier: NCT00470041     History of Changes
Other Study ID Numbers: 2007/155
First Submitted: May 4, 2007
First Posted: May 7, 2007
Last Update Posted: June 16, 2010
Last Verified: June 2010

Keywords provided by University Ghent:
Healthy volunteers

Additional relevant MeSH terms:
Lamivudine
Zidovudine
Lamivudine, zidovudine drug combination
Antiviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-Infective Agents
Anti-HIV Agents
Antimetabolites