Last updated: 11/04/2018 13:51:38
Bioequivalence study of Aciclovir 5% cream in Japanese Healthy Volunteers
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Bioequivalence study of Aciclovir 5% cream - Bioequivalence study of Aciclovir cream between Current and New formulation in Japanese Healthy volunteers -
Trial description: 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
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Bioequivalence of Aciclovir amount in keratin layer of the epidermis between Current and New formulation of Aciclovir cream
Timeframe: One day
Secondary outcomes:
To investigate the safety and tolerability of New and Current formulation of Aciclovir Cream 5% following single topical application in healthy Japanese male subjects
Timeframe: One day
Interventions:
Drug: New formulation
Drug: Current formulation
Enrollment:
27
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Herpes Labialis
Product
aciclovir
Collaborators
Not applicable
Study date(s)
April 2008 to August 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
20 - 55 years
Accepts healthy volunteers
Yes
- 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
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-17-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study ZVC111449 can be found on the GSK Clinical Study Register.
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