- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06233162
Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets
A Bioequivalence Study of a Randomized, Open-label, Single Dose, Two-way Crossover Design With Two-period, Two-treatment and Two-sequence of Febuxostat 80 mg Tablets Relative to Feburic® in Healthy Thai Volunteers Under Fasting Condition
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Title A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Febuxostat 80 mg tablets relative to Feburic® 80 mg tablets in healthy Thai volunteers under fasting condition.
Objectives The primary objective is to compare the rate and extent of absorption of a generic formulation with that of a reference formulation when given as equal labeled dose. The secondary objective is to evaluate the safety after oral administration of both test and reference formulation in healthy Thai volunteers.
Study Design Randomized, open-label, single dose, two-way crossover design with two-period, two-treatment, and two-sequence under fasting condition and at least 7 days washout period between the doses.
Sample Size 46 Healthy Human Thai subjects. Four extra subjects if available, may be checked-in on the day of check in of period-I to compensate for any dropout prior to dosing of period-I. These subjects will be dosed if there are dropouts prior to dosing in period-I. If there are no dropouts, these subjects will be checked-out without being dosed after completion of dosing in period-I.
Drug-Product Test-Product: Febuxostat 80 mg tablets Reference-product: Feburic® 80 mg tablets Manufactured by: Patheon France, France
Administration After an overnight fasting at clinical facility of at least 10 hours, each volunteer will receive a single dose of Febuxostat 80 mg tablets of either test or reference with 250 mL of drinking water. Each volunteer will be allowed to drink water as desire except 1 hour before and after drug administration. The formulation is given in a crossover fashion as per the randomization schedule. After the administration, the subject's oral cavity will be checked by using flashlight to confirm complete medication and fluid consumption by pharmacist.
Blood Schedule In each period, a total of 20 blood samples (approximately 7 mL each) will be collected pre-dose (0.000 hour) and at 0.167, 0.333, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.500, 3.000, 3.500, 4.000, 6.000, 8.000, 10.000, 12.000, 18.000 and 24.000 hours after study drug administration, respectively.
Sample Collection Blood samples will be collected through an indwelling catheter placed in a vein using disposable syringe or through fresh venipuncture with disposable syringes and needles. Approximately 7 mL blood sample will be withdrawn and transferred to sample collection pre-labeled tubes containing K3EDTA as anticoagulant at each sampling time point. After collection of blood samples from each subject at each time point, samples will be centrifuged at 4000 rpm for 5 minutes at 4±2°C. After centrifugation, the plasma samples will be aliquot into two pre-labeled cryovials for approximately 1 mL per each cryovial. Cryovials containing plasma sample will be stored at -70±10 °C.
Analytical Method Febuxostat plasma concentration will be assayed as per international Guidelines/In-house SOP by using a UPLC-MS/MS method.
Pharmacokinetic Parameters Primary pharmacokinetic parameter: Cmax, AUC0→t and AUC0→∞ and secondary pharmacokinetic parameter: Tmax, T1/2, Kel, AUC0→t/AUC0→∞ will be determined from the plasma concentration data of analytes.
Statistical Analysis ANOVA, two one-sided tests for bioequivalence, for log-transformed pharmacokinetic parameters Cmax, AUC0→t and AUC0→∞ will be performed.
Acceptance Criteria for Bioequivalence To be considered as bioequivalent, the 90% Confidence Interval of the geometric means ratio of Cmax, AUC0→t and AUC0→∞ of Febuxostat of test and reference products should be in the interval of 80.00-125.00% for the log-transformed data.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Sasitorn Kittivoravitkul, Ph.D.
- Phone Number: 022549008
- Email: sasitorn_k@bio-innova.com
Study Contact Backup
- Name: Somkiat Tatritorn, M.D.
- Phone Number: 022549008
- Email: somkiat_t@bio-innova.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
13.4.1 Inclusion Criteria
- Willingness to provide written informed consent prior to participate in the study.
- Healthy Thai subjects are between 18 to 55 years of age.
- The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2.
- Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects' safety after the completion of the study.
- Negative urine pregnancy test for women and no breast-feeding.
- Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.
Exclusion Criteria:
13.4.2 Exclusion Criteria
- History or evidence of allergy or hypersensitivity to Febuxostat or any of the excipients of this product.
- Subject with B.P. is Systolic B.P < 90, ≥ 140 mm/Hg, Diastolic B.P < 60, ≥ 90 mm/Hg or pulse rate > 100 beats per minute.
- Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).*
- Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).*
- Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).*
- Positive of hepatitis B or C virus.
- Have more than one abnormal EKG, which is considered as clinically significant. *
- History or evidence of heart (unstable angina pectoris, myocardial infarction, cardiovascular), stroke, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, diabetes mellitus with vascular disease, gout disease, hypertension or glaucoma.
- History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
- Any major illness in the past 3 months or any significant ongoing chronic medical illness.
- History of psychiatric disorder.
- History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
- History of usually smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of the study.
- High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
- Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids).
- Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-Provera must be discontinued at least 6 months) prior to receiving the first dose of study medication.
- History of difficulty in accessibility of veins in left and right arm.
- Blood donation (one unit or 450 mL) within the past 3 months before the study.
- Participation in any clinical study within the past 3 months before the study.
- Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
(* Depend on decision of principal investigator and/or clinical investigator)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sequence 1-Febuxostat test product and then reference product
Participants will receive treatment 1 in period 1 and treatment 2 in period 2.
Where treatment 1= Febuxostat 80 mg tablets test product, treatment 2= Febuxostat 80 mg tablets reference product.
|
Febuxostat 80 mg tablets Manufactured by: Zydus Lifesciences Limited, India
|
Experimental: Sequence 2-Febuxostat reference product and then test product
Participants will receive treatment 2 in period 1 and treatment 1 in period 2.
Where treatment 1= Febuxostat 80 mg tablets test product, treatment 2= Febuxostat 80 mg tablets reference product.
|
Febuxostat 80 mg tablets Manufactured by: Patheon France, France
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t)
Time Frame: Blood samples will be collected for PK analyses in each period pre-dose (0.000 hour) and at 0.167, 0.333, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.500, 3.000, 3.500, 4.000, 6.000, 8.000, 10.000, 12.000, 18.000 and 24.000 hours post-dose
|
pre-dose (0.000 hour) and at 0.167, 0.333, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.500, 3.000, 3.500, 4.000, 6.000, 8.000, 10.000, 12.000, 18.000 and 24.000 hours post-dose
|
Blood samples will be collected for PK analyses in each period pre-dose (0.000 hour) and at 0.167, 0.333, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.500, 3.000, 3.500, 4.000, 6.000, 8.000, 10.000, 12.000, 18.000 and 24.000 hours post-dose
|
Maximal measured plasma concentration (Cmax)
Time Frame: Blood samples will be collected for PK analyses in each period pre-dose (0.000 hour) and at 0.167, 0.333, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.500, 3.000, 3.500, 4.000, 6.000, 8.000, 10.000, 12.000, 18.000 and 24.000 hours post-dose
|
pre-dose (0.000 hour) and at 0.167, 0.333, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.500, 3.000, 3.500, 4.000, 6.000, 8.000, 10.000, 12.000, 18.000 and 24.000 hours post-dose
|
Blood samples will be collected for PK analyses in each period pre-dose (0.000 hour) and at 0.167, 0.333, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.500, 3.000, 3.500, 4.000, 6.000, 8.000, 10.000, 12.000, 18.000 and 24.000 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with adverse events
Time Frame: Approximately the day 14 after the last visit
|
An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
Approximately the day 14 after the last visit
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FEB-031-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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