Official Title: “Bioequivalence Study of Aciclovir 5% Cream - Bioequivalence Study of Aciclovir Cream Between Current and New Formulation in Japanese Healthy Volunteers -”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Single Group Assignment, Bio-equivalence Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: New formulation
  • New formulation of Aciclovir Cream 5% scheduled to be substituted to Current formulation in Japan
• Drug: Current formulation
  • Current formulation of Aciclovir Cream 5% in Japan

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Current formulation
• Experimental: New formulation

Primary Measures

• Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream
  • Time Frame: One day
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00711776

Study ID Number: ZVC111449

ClinicalTrials.gov Identifier: NCT00711776

Health Authority: Japan: Ministry of Health, Labor and Welfare