Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers

Herpes Labialis Clinical Trial

Official title:

Bioequivalence Study of Aciclovir 5% Cream - Bioequivalence Study of Aciclovir Cream Between Current and New Formulation in Japanese Healthy Volunteers -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711776
• Other study ID #: ZVC111449
• Status: Completed
• Phase: Phase 1
• Start date: April 10, 2008
• Est. completion date: August 17, 2008

Study information

• Verified date: August 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 17, 2008
• Est. primary completion date: August 17, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Labialis

Intervention

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

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream		One day
Secondary	To investigate the safety and tolerability of New and Current formulation of Aciclovir Cream 5% following single topical application in healthy Japanese male subjects		One day

External Links

•   Results for study ZVC111449 can be found on the GSK Clinical Study Register.