Status:
COMPLETED
Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Herpes Labialis
Eligibility:
MALE
20-55 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 10 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2008
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00711776
Start Date
April 10 2008
End Date
August 17 2008
Last Update
August 31 2018
Active Locations (1)
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1
GSK Investigational Site
Tokyo, Japan, 160-0017