Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00711776

Purpose

This study is designed to show bioequivalence between Current and New formulation of Aciclovir cream 5% in keratin layer of the epidermis in Japanese Subjects

Condition	Intervention	Phase
Healthy Subjects	Drug: New formulation Drug: Current formulation	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Bio-equivalence Study
Official Title:	Bioequivalence Study of Aciclovir 5% Cream - Bioequivalence Study of Aciclovir Cream Between Current and New Formulation in Japanese Healthy Volunteers -

Resource links provided by NLM:

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream [ Time Frame: One day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To investigate the safety and tolerability of New and Current formulation of Aciclovir Cream 5% following single topical application in healthy Japanese male subjects [ Time Frame: One day ] [ Designated as safety issue: No ]

Enrollment:	27
Study Start Date:	April 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Current formulation: Active Comparator	Drug: Current formulation Current formulation of Aciclovir Cream 5% in Japan
New formulation: Experimental	Drug: New formulation New formulation of Aciclovir Cream 5% scheduled to be substituted to Current formulation in Japan

Eligibility

Ages Eligible for Study:	20 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Japanese adult males between 20 and 55 years of age, inclusive.

Healthy subjects are defined as individuals who are free from clinically significant disease as determined by their medical history, physical examination, clinical laboratory examinations, vital sign, 12-lead ECG, immunology tests and urinary drug screen test.

Bodyweight >50 kg and body mass index (BMI) between 18.5 and 28.0 at screening.
Subjects must be capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Baseline QTc interval <450 msec.
Non-smoker or ex-smoker having ceased smoking for at least 6 months.
Clinical laboratory examination (AST, ALT, ALP and GGT) at screening are within the normal range.
The subject is able to attend all visits and complete the study.

Exclusion Criteria:

Any clinically relevant abnormality identified on the screening physical examination, vital sign measurement, 12-lead ECG recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern.
History of regular alcohol consumption exceeding, on average, 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening.
Positive for urine drug at screening.
Positive for syphilis, HIV antibody, Hepatitis B surface antigen, Hepatitis C antibody or HTLV-1 antibody at screening.
Donation of blood in excess of 400mL within 4 months or 200mL within 1 months prior to at screening.
History of drug abuse, or current conditions of drug abuse or alcoholism.
Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first application of study medication.
Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device.
History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses.
The subject has an allergy for any drug or idiosyncrasy. This excludes a pollen allergy without current symptoms.
At the part obtaining keratinized layer, having exanthem, pigment abnormality, the skin symptoms such as wounds and/or an excessive sunburn.
History of clinically significant itching, erythema and/or rash by any paster.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711776

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ZVC111449
Study First Received:	July 3, 2008
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00711776 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

Bioequivalence
Aciclovir cream 5%
Japanese
Male
Volunteer

Additional relevant MeSH terms:

Anti-Infective Agents
Acyclovir
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009