Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence.

Gout Clinical Trial

Official title:

A Randomized, Open-label, Replicate, Crossover, 4-period Study to Assess the Bioequivalence of Lesinurad/Allopurinol Fixed-dose Combination 200/300 mg Tablets From Ardea Biosciences, Inc. (Test Drug) Versus Lesinurad, 200 mg Tablet From AstraZeneca (Comparator 1) Coadministered With Zyloric®, Allopurinol 300 mg Tablet From Aspen Pharma Industria Farmaceutica Ltda. (Comparator 2) in Healthy Female and Male Adult Subjects, Under Fasting Conditions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272425
• Other study ID #: RDEA594-504
• Status: Completed
• Phase: Phase 1
• Start date: August 14, 2017
• Est. completion date: October 4, 2017

Study information

• Verified date: November 2018
• Source: Ardea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fasted state based on the pharmacokinetic (PK) evaluation of lesinurad and allopurinol in healthy adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 4, 2017
• Est. primary completion date: October 4, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body mass index ranging between 18.5 kg/m2 and 30 kg/m2.

• Screening serum urate level is = 7.0 mg/dL.

Exclusion Criteria:

• Asian subject who has a positive test for the HLA-B*5801 allele.

• History or current diagnosis of kidney stones.

• Estimated creatinine clearance, as determined at Screening, of = 80 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.

• Undergone major surgery within 3 months prior to Screening.

• Donated blood within 4 weeks prior to Day 1 or experienced an event (other than blood donation) of significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or has given a plasma donation within 4 weeks prior to Day 1.

• Inadequate venous access or unsuitable veins for repeated venipuncture.

• Received any strong or moderate enzyme-inducing drug or product within 2 months prior to Screening.

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• lesinurad/allopurinol 200/300 FDC tablets
Test Drug
• lesinurad 200 mg
Comparator 1
• allopurinol 300 mg
Comparator 2

Locations

Country	Name	City	State
Brazil	CAEP - Centro Avançado de Estudos e Pesquisas Ltda.	Campinas	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Ardea Biosciences, Inc.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) endpoints in terms of maximum observed concentration (Cmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets	Cmax is the maximum observed concentration of a drug after administration	Days 1, 8, 15 and 22
Primary	PK endpoints in terms of area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint (AUC last) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets	AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint	Days 1, 8, 15 and 22
Primary	PK endpoints in terms of area under the plasma concentration time curve from and from zero to infinity (AUC 0-8) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets	AUC 0-8 is a meausre of total concentration from time zero to infinity	Days 1, 8, 15 and 22
Primary	PK endpoints in terms of time of occurrence of maximum observed concentration (tmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets	Tmax is the time of occurrence of cmax	Days 1, 8, 15 and 22
Primary	PK endpoints in terms of apparent terminal half-life (t1/2) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets	t1/2 is a measure of apparent terminal half-life	Days 1, 8, 15 and 22
Secondary	Incidence of Adverse Events in terms of changes in laboratory parameters		26 days
Secondary	Incidence of Adverse Events in terms of electrocardiogram parameters		26 days
Secondary	Incidence of Adverse Events in terms of vital signs		26 days
Secondary	Incidence of Adverse Events in terms of physical examination findings		26 days