Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers

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 Overview

• Status: Completed
• Conditions: Herpes Labialis
• Intervention / Treatment: Drug: New formulation; Drug: Current formulation

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 160-0017
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Subjects receiving new formulation in blank test group; Eligible subjects will receive acyclovir cream 5 % following single topical application.	Drug: New formulation; New formulation of Aciclovir Cream 5% scheduled to be substituted to Current formulation in Japan
ACTIVE_COMPARATOR: Subjects receiving current formulation in blank test group; Eligible subjects will receive acyclovir cream 5 % following single topical application.	Drug: Current formulation; Current formulation of Aciclovir Cream 5% in Japan
EXPERIMENTAL: Subjects receiving new formulation in pre-test group; Eligible subjects will receive acyclovir cream 5 % following single topical application.	Drug: New formulation; New formulation of Aciclovir Cream 5% scheduled to be substituted to Current formulation in Japan
ACTIVE_COMPARATOR: Subjects receiving current formulation in pre-test group; Eligible subjects will receive acyclovir cream 5 % following single topical application.	Drug: Current formulation; Current formulation of Aciclovir Cream 5% in Japan
EXPERIMENTAL: Subjects receiving new formulation in main-test group; Eligible subjects will receive acyclovir cream 5 % following single topical application.	Drug: New formulation; New formulation of Aciclovir Cream 5% scheduled to be substituted to Current formulation in Japan
ACTIVE_COMPARATOR: Subjects receiving current formulation in main-test group; Eligible subjects will receive acyclovir cream 5 % following single topical application.	Drug: Current formulation; Current formulation of Aciclovir Cream 5% in Japan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream	One day

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2008
• Primary Completion (ACTUAL): August 17, 2008
• Study Completion (ACTUAL): August 17, 2008

Study Registration Dates

• First Submitted: July 3, 2008
• First Submitted That Met QC Criteria: July 8, 2008
• First Posted (ESTIMATE): July 9, 2008

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Bioequivalence; Japanese; Male; Volunteer; Aciclovir cream 5%
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Lip Diseases; Herpes Simplex; Herpes Labialis
• Other Study ID Numbers: ZVC111449