Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers

NCT00711776 | Completed Phase 1

• 1 other identifier: ZVC111449
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Herpes Labialis

Keywords

Aciclovir cream 5%; Volunteer; Japanese; Male; Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream

  One day

Secondary Outcomes (1)

• 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

Study Arms (6)

Subjects receiving new formulation in blank test group

EXPERIMENTAL

Eligible subjects will receive acyclovir cream 5 % following single topical application.

Drug: New formulation

Subjects receiving current formulation in blank test group

ACTIVE COMPARATOR

Eligible subjects will receive acyclovir cream 5 % following single topical application.

Drug: Current formulation

Subjects receiving new formulation in pre-test group

EXPERIMENTAL

Eligible subjects will receive acyclovir cream 5 % following single topical application.

Drug: New formulation

Subjects receiving current formulation in pre-test group

ACTIVE COMPARATOR

Eligible subjects will receive acyclovir cream 5 % following single topical application.

Drug: Current formulation

Subjects receiving new formulation in main-test group

EXPERIMENTAL

Eligible subjects will receive acyclovir cream 5 % following single topical application.

Drug: New formulation

Subjects receiving current formulation in main-test group

ACTIVE COMPARATOR

Eligible subjects will receive acyclovir cream 5 % following single topical application.

Drug: Current formulation

Interventions

New formulation DRUG

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

Subjects receiving new formulation in blank test group; Subjects receiving new formulation in main-test group; Subjects receiving new formulation in pre-test group

Current formulation DRUG

Current formulation of Aciclovir Cream 5% in Japan

Subjects receiving current formulation in blank test group; Subjects receiving current formulation in main-test group; Subjects receiving current formulation in pre-test group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Tokyo, 160-0017, Japan

Location

Related Links

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

MeSH Terms

Conditions

Herpes Labialis

Condition Hierarchy (Ancestors)

Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 9, 2008
• Study Start: April 10, 2008
• Primary Completion: August 17, 2008
• Study Completion: August 17, 2008
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

JP (1)