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Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00711776
First Posted: July 9, 2008
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]

Enrollment: 27
Actual Study Start Date: April 10, 2008
Study Completion Date: August 17, 2008
Primary Completion Date: August 17, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711776


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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00711776     History of Changes
Other Study ID Numbers: ZVC111449
First Submitted: July 3, 2008
First Posted: July 9, 2008
Last Update Posted: August 4, 2017
Last Verified: August 2017

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