A Phase 1 interventional study of Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) and Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) in Clinical Pharmacology, sponsored by Bayer. Completed at 1 site in Japan. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-21.
Sponsored by Bayer · Phase 1, Interventional, and Treatment
The primary objective of this study was to establish the bioequivalence of two different tablet formulations containing BAY77-1931. The secondary objectives of this study were to assess the safety and tolerability, as well as to Investigate the plasma lanthanum concentration after BAY 77-1931 ODT 500 mg administration.
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Exclusion Criteria:
Fosrenol BAY 77-1931 orally disintegrating tablet (ODT) 500 mg in Period 1 (day 1-3) and Fosrenol chewable tablet 500mg in Period 2 (day 4-6). The washout interval between period 1 and 2 will be at least 14 days.
Drug: Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)
Fosrenol BAY77-1931 chewable tablet in Period 1 and Fosrenol BAY 77-1931 ODT 500 mg in Period 2. The washout interval between period 1 and 2 will be at least 14 days.
Drug: Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)
Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID
Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID
Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each day
Each study drug was administered as multiple dose over 4-days under fed conditions with a washout interval of at least 14 days in between. Twenty four hours urine collection were repeated 5 times from morning on Day -2 to that on Day 4.
Time frame: 6 days
Bioequivalence: Average of daily urinary phosphate excretion (mmol) over 3-day dosing period
During lanthanum carbonate TID treatment period over 3 days in each period (period 1 = day 1-3; period 2 = day 4-6)
Time frame: baseline and over 3-days
Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3
Time frame: 1 day
Plasma lanthanum concentrations (ng/mL)
To measure plasma concentration of lanthanum, 6 mL of blood were collected before the breakfast on Day 1, Day 2, Day 3 and Day 4, and at 1, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours after administration on Day 4.
Time frame: 6 days
Pharmacokinetics: Cmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Time frame: 6 days
Pharmacokinetics: tmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Time frame: 6 days
Pharmacokinetics: Cmax,md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Time frame: 6 days
Pharmacokinetics: AUC(0-tlast)md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Time frame: 6 days
Pharmacokinetics: t1/2,md of lanthanum in plasmafrom pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Time frame: 6 days
Number of adverse events as a measure of safety and tolarability
Time frame: From Day 1, the day of the first study drug administration, in period 1 (day 1-3) to follow up, 7-10 days after the last study drug administration in period 2 (day 4 - 6)
Pharmacokinetics: AUC(0-tlast)md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
Time frame: 6 days
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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