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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00470041

Enrollment

Registered

2007-05-07

Start date

2007-06-30

Completion date

2009-12-31

Last updated

2010-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volunteers

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.

Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

* 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

Design outcomes

Primary

Measure	Time frame
bioavailability of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation (trial formulation) especially designed for pediatric use	over 24 hours

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026