Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00711776
First received: July 3, 2008
Last updated: March 21, 2013
Last verified: March 2013
  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
Herpes Labialis
Drug: New formulation
Drug: Current formulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
Active Comparator: Current formulation Drug: Current formulation
Current formulation of Aciclovir Cream 5% in Japan
Experimental: New formulation 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
GSK Investigational Site
Tokyo, Japan, 160-0017
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00711776     History of Changes
Other Study ID Numbers: ZVC111449
Study First Received: July 3, 2008
Last Updated: March 21, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Aciclovir cream 5%
Volunteer
Japanese
Male
Bioequivalence

Additional relevant MeSH terms:
Herpes Labialis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases, Infectious
Skin Diseases
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014