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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

July 3, 2008
March 21, 2013
April 2008
August 2008   (final data collection date for primary outcome measure)
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 ]
Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream
Complete list of historical versions of study NCT00711776 on ClinicalTrials.gov Archive Site
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 ]
To investigate the safety and tolerability of New and Current formulation of Aciclovir Cream 5% following single topical application in healthy Japanese male subjects
Not Provided
Not Provided
 
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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Herpes Labialis
  • 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
  • Active Comparator: Current formulation
    Intervention: Drug: Current formulation
  • Experimental: New formulation
    Intervention: Drug: New formulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Male
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00711776
ZVC111449
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2013

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