NCT00470041

CompletedPhase 1

Bioavailability Study of a New Pediatric Formulation of Zido...

University Ghent Source

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Other study identifiers

Sponsor study identifier

2007/155

Study Type

interventional

Estimated enrollment

12

Locations

1 country

Sites

1

Timeline

Study Start

June 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2009

Actual (reported)

Study Completion

December 2009

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 12 participants
Study completion date: December 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 4, 2007
Actual (reported)
First Posted
May 7, 2007
Actual (reported)
Study Start
June 2007
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
October 2009
Actual (reported)
Study Completion
December 2009
Actual (reported)

Last Updated: June 16, 2010
Status Verified: June 2010
Last Update Submitted: June 15, 2010

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 formulationDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

University Ghent
Otherlead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

MeSH Terms

Interventions

LamivudineZidovudine

Intervention Hierarchy (Ancestors)

ZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

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 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2009

Actual (reported)

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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

Contact the study team to confirm eligibility.

Study Completion

December 2009

Actual (reported)

Last Updated

June 16, 2010

Record last verified: 2010-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00470041
Data provider: ClinicalTrials.gov
Source updated: 2010-06-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:36 UTC

Locations

BE(1)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations