A Relative Bioavailability Study of Griseofulvin 125 mg/5 mL Suspension Under Fasting Conditions
Information source: Actavis Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Griseofulvin 125 mg/5 mL Suspension, single dose (Drug); Grifulvin V® 125 mg/5 mL Suspension, single dose (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Actavis Inc. Official(s) and/or principal investigator(s): Paul Y. Tam,, MD, Principal Investigator, Affiliation: Biovail Contract Research
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Rate and Extend of Absorption
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Non-smoking male or female with a minimum age of 18 years.
2. Body Mass Index (BMI = weight/height2) greater than or equal to 18. 5 kg/m2 and less
than or equal to 29. 9 kg/m2.
3. 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).
4. Negative for drugs of abuse and nicotine.
5. Negative for hepatitis B-surface antigen, hepatitis C and HIV.
6. Female subjects: negative for pregnancy (as evaluated by serum β-CG test).
7. No clinical laboratory values outside of the acceptable range as defined by BCR,
unless the Principal Investigator decides that they are not clinically significant.
8. 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.
9. 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:
1. Known history of hypersensitivity to griseofulvin (e. g. Grifulvin V®, gris-PEG®,
Fulvicin®) penicillin, or drugs derived from the same species of Penicillium.
2. 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.
3. Presence of any significant physical or organ abnormality.
4. Any history or evidence of psychiatric or psychological disease (including
depression) unless deemed not clinically significant by the Principal Investigator or
Sub-investigator.
5. History of presence of any skin conditions (e. g. dermatitis, eczema, psoriasis).
6. Presence of any skin rashes.
7. Any subject who has been previously diagnosed with porphyria.
8. Any clinically significant illness during the 4 weeks before this study.
9. 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.
10. Known history or presence of food allergies, or any condition known to interfere with
the absorption, distribution, metabolism or excretion of drugs.
11. Any history of severe allergic reaction (including drugs, food, insect bites,
environmental allergens).
12. Significant or recent history of asthma (after 12 years of age).
13. Any subject with a history of drug abuse.
14. Any subject with a recent (less than 1 year) history of alcohol abuse.
15. Use of any prescription medication within 14 days preceding this study.
16. Use of over-the-counter (OTC) medication within 7 days preceding this study (except
for spermicidal/barrier contraceptive products).
17. 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.
18. Female subjects: evidence of pregnancy or lactation.
19. 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.
20. Participation in a clinical trial with an investigational drug within 30 days
preceding this study.
21. Any subject who has donated blood within 56 days preceding this study.
22. Any subject who has participated as a plasma donor in a plasmapheresis program within
7 days preceding this study.
23. Any subject who has adhered to a significantly abnormal diet during the 4 weeks
preceding the first dose of the study.
24. Intolerance to venipuncture.
Locations and Contacts
Biovail Contract Research (A Division of Biovail Corporation), Toronto, Ontario M1L 4S4 / M1L 4R6, Canada
Additional Information
GRISEOFULVIN
Starting date: November 2005
Last updated: August 13, 2010
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