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

This study has been completed.
Sponsor:
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT00470041
First received: May 4, 2007
Last updated: June 15, 2010
Last verified: June 2010
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Prof. Dr. Luc Van Bortel, University Ghent
ClinicalTrials.gov Identifier: NCT00470041     History of Changes
Other Study ID Numbers: 2007/155
Study First Received: May 4, 2007
Last Updated: June 15, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Ghent:
Healthy volunteers

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

ClinicalTrials.gov processed this record on July 22, 2014