Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers
Status and phase
Completed
Phase 1
Conditions
Herpes Labialis
Treatments
Drug: Current formulation
Drug: New formulation
Details and patient eligibility
About
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
Enrollment
27 patients
Sex
Male
Ages
20 to 55 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
27 participants in 6 patient groups
Subjects receiving new formulation in blank test group
Experimental group
Description:
Eligible subjects will receive acyclovir cream 5 % following single topical application.
Treatment:
Drug: New formulation
Subjects receiving current formulation in blank test group
Active Comparator group
Description:
Eligible subjects will receive acyclovir cream 5 % following single topical application.
Treatment:
Drug: Current formulation
Subjects receiving new formulation in pre-test group
Experimental group
Description:
Eligible subjects will receive acyclovir cream 5 % following single topical application.
Treatment:
Drug: New formulation
Subjects receiving current formulation in pre-test group
Active Comparator group
Description:
Eligible subjects will receive acyclovir cream 5 % following single topical application.
Treatment:
Drug: Current formulation
Subjects receiving new formulation in main-test group
Experimental group
Description:
Eligible subjects will receive acyclovir cream 5 % following single topical application.
Treatment:
Drug: New formulation
Subjects receiving current formulation in main-test group
Active Comparator group
Description:
Eligible subjects will receive acyclovir cream 5 % following single topical application.
Treatment:
Drug: Current formulation
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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