- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00863863
A Relative Bioavailability Study of Griseofulvin 125 mg/5 mL Suspension Under Non-fasting Conditions
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
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
Study Type: Interventional Study Design: A randomized, two-way crossover, open-label, single-dose, fed 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
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Opiskelupaikat
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Ontario
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Toronto, Ontario, Kanada, M1L 4S4 / M1L 4R6
- Biovail Contract Research (A Division of Biovail Corporation)
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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/m2.
- 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.
- 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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: A
Griseofulviini 125 mg/5 ml Suspensio, kerta-annos
|
A: Experimental Subjects received Alpharma formulated products under non-fasting conditions
Muut nimet:
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Active Comparator: B
Grifulvin V® 125 mg/5 ml suspensio, kerta-annos
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B: Active comparator Subjects received Ortho Neutrogena formulated products under non-fasting conditions
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
---|---|
Imeytymisnopeus ja -pituus
Aikaikkuna: 120 tuntia
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120 tuntia
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Paul Y. Tam,, MD, Biovail Contract Research
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 3155
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