A Phase 1 interventional study of ABP-671 in Gout and Food-drug Interaction, sponsored by Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-23.
Sponsored by Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
This is a single center, open-label, single-dose, 2-way randomized crossover design in which 12 healthy subjects will be randomized to 1 of 2 treatment sequences (AB or BA). Treatments A and B will consist of single oral dose of tablet formulation (1.0 mg as 1 x 1.0 mg) in the fasted and fed state administered with approximately 240 mL of water. Each period will be separated by a washout interval of 4 days.
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single 1.0 mg dose of ABP-671 in the fasted state.
Drug: ABP-671
Single 1.0 mg dose of ABP-671 in the fed state, after a standardized breakfast.
Drug: ABP-671
ABP-671 Tablet 1.0 mg
Plasma ABP-671 Concentration
At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.
Time frame: 72 hours
Serum Uric Acid Concentration
At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.
Time frame: 72 hours
Serum Creatinine Concentration
At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.
Time frame: 72 hours
Urine Uric Acid Concentration
At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.
Time frame: 72 hours
Urine Creatinine Concentration
At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.
Time frame: 72 hours
Plan to share: No
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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.