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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: May 7, 2007
Registry last updated: Jun 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed