NCT00864071CompletedPhase 1
A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study Of Griseofulvin 125 mg/5 mL Suspension Versus Grifulvin V® 125 mg/5 mL Suspension In Normal, Healthy, Non-Smoking Male And Female Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Actavis Inc.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Rate and Extend of Absorption
Study Overview
Brief Summary
To compare the rate and extent of absorption of griseofulvin from a test formulation of Griseofulvin 125 mg/5 mL Suspension versus the reference Grifulvin V® 125 mg/5 mL Suspension under fasting conditions.
Detailed Description
Study Type: Interventional Study Design: A randomized, two-way crossover, open-label, single-dose, fasting design.
Official Title: A TWO-WAY CROSSOVER, OPEN-LABEL, SINGLE-DOSE, FED, BIOEQUIVALENCE STUDY OF GRISEOFULVIN 125 mg/5 mL SUSPENSION VERSUS GRIFULVIN V® 125 mg/5 mL SUSPENSION IN NORMAL, HEALTHY, NON-SMOKING MALE AND FEMALE SUBJECTS
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Non-smoking male or female with a minimum age of 18 years.
- •Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m
- •Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats/minute, temperature between 35.8°C and 37SC).
- •Negative for drugs of abuse and nicotine.
- •Negative for hepatitis B-surface antigen, hepatitis C and HIV.
- •Female subjects: negative for pregnancy (as evaluated by serum β-CG test).
- •No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides that they are not clinically significant.
- •Female subjects who are surgically sterile for at least 6 months or post-menopausal for at least 1 year, or who will avoid pregnancy for at least 10 days before the study, during the study and up until 1 month after the end of the study.
- •Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements, as evidenced by a signed ICF.
Exclusion Criteria
- •Known history of hypersensitivity to griseofulvin (e.g. Grifulvin V®, gris-PEG®, Fulvicin®) penicillin, or drugs derived from the same species of Penicillium.
- •Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
- •Presence of any significant physical or organ abnormality.
- •Any history or evidence of psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
- •History of presence of any skin conditions (e.g. dermatitis, eczema, psoriasis).
- •Presence of any skin rashes.
- •Any subject who has been previously diagnosed with porphyria.
- •Any clinically significant illness during the 4 weeks before this study.
- •Any subject who has been treated with any known enzyme-altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of the study medication.
- •Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- •Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).
- •Significant or recent history of asthma (after 12 years of age).
- •Any subject with a history of drug abuse.
- •Any subject with a recent (less than 1 year) history of alcohol abuse.
- •Use of any prescription medication within 14 days preceding this study.
- •Use of over-the-counter (OTC) medication within 7 days preceding this study (except for spermicidal/barrier contraceptive products).
- •Female subjects: use of contraceptives (oral, emergency [Plan B®], transdermal, implant, Mirena® IUD, NuvaRing®) within 30 days before drug administration or a depot injection of progestogen drug (e.g. Depo-Provera®) within 1 year before drug administration.
- •Female subjects: evidence of pregnancy or lactation.
- •Any subject who has had blood drawn within 56 days preceding this study, during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.
- •Participation in a clinical trial with an investigational drug within 30 days preceding this study.
- •Any subject who has donated blood within 56 days preceding this study.
- •Any subject who has participated as a plasma donor in a plasmapheresis program within 7 days preceding this study.
- •Any subject who has adhered to a significantly abnormal diet during the 4 weeks preceding the first dose of the study.
- •Intolerance to venipuncture.
Arms & Interventions
A
Experimental
Griseofulvin 125 mg/5 mL Suspension, single dose
Intervention: Griseofulvin 125 mg/5 mL Suspension, single dose (Drug)
B
Active Comparator
Grifulvin V® 125 mg/5 mL Suspension, single dose
Intervention: Grifulvin V® 125 mg/5 mL Suspension, single dose (Drug)
Outcomes
Primary Outcomes
Rate and Extend of Absorption
Time Frame: 120 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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