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Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00711776
Recruitment Status : Completed
First Posted : July 9, 2008
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE July 3, 2008
First Posted Date  ICMJE July 9, 2008
Last Update Posted Date August 31, 2018
Actual Study Start Date  ICMJE April 10, 2008
Actual Primary Completion Date August 17, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream [ Time Frame: One day ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2008)
Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream
Change History Complete list of historical versions of study NCT00711776 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2008)
To investigate the safety and tolerability of New and Current formulation of Aciclovir Cream 5% following single topical application in healthy Japanese male subjects
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers
Official Title  ICMJE Bioequivalence Study of Aciclovir 5% Cream - Bioequivalence Study of Aciclovir Cream Between Current and New Formulation in Japanese Healthy Volunteers -
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Herpes Labialis
Intervention  ICMJE
  • Drug: New formulation
    New formulation of Aciclovir Cream 5% scheduled to be substituted to Current formulation in Japan
  • Drug: Current formulation
    Current formulation of Aciclovir Cream 5% in Japan
Study Arms  ICMJE
  • Experimental: Subjects receiving new formulation in blank test group
    Eligible subjects will receive acyclovir cream 5 % following single topical application.
    Intervention: Drug: New formulation
  • Active Comparator: Subjects receiving current formulation in blank test group
    Eligible subjects will receive acyclovir cream 5 % following single topical application.
    Intervention: Drug: Current formulation
  • Experimental: Subjects receiving new formulation in pre-test group
    Eligible subjects will receive acyclovir cream 5 % following single topical application.
    Intervention: Drug: New formulation
  • Active Comparator: Subjects receiving current formulation in pre-test group
    Eligible subjects will receive acyclovir cream 5 % following single topical application.
    Intervention: Drug: Current formulation
  • Experimental: Subjects receiving new formulation in main-test group
    Eligible subjects will receive acyclovir cream 5 % following single topical application.
    Intervention: Drug: New formulation
  • Active Comparator: Subjects receiving current formulation in main-test group
    Eligible subjects will receive acyclovir cream 5 % following single topical application.
    Intervention: Drug: Current formulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2009)
27
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2008)
29
Actual Study Completion Date  ICMJE August 17, 2008
Actual Primary Completion Date August 17, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00711776
Other Study ID Numbers  ICMJE ZVC111449
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP