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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: administration of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: administration of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers