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

NCT00470041 | Completed Phase 1

• 1 other identifier: 2007/155
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

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

  over 24 hours

Interventions

administration of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Website University Hospital Ghent

MeSH Terms

Interventions

Lamivudine; Zidovudine

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine

Study Officials

• Luc Van Bortel, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2007
• First Posted: May 7, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 16, 2010

Record last verified: 2010-06

Locations

BE (1)