check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
18060
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Bioequivalence study of BAY 77-1931 orally disintegrating tablet
Trial purpose
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.
Key Participants Requirements
Sex
MaleAge
20 - 45 YearsTrial summary
Enrollment Goal
20Trial Dates
June 2015 - August 2015Phase
Phase 1Could I Receive a placebo
NoProducts
Fosrenol (Lanthanum Carbonate, BAY77-1931)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Fukuoka, 812-0025, Japan |
Primary Outcome
- Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each dayEach 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.date_rangeTime Frame:6 daysenhanced_encryptionNoSafety Issue:
- Bioequivalence: Average of daily urinary phosphate excretion (mmol) over 3-day dosing periodDuring lanthanum carbonate TID treatment period over 3 days in each period (period 1 = day 1-3; period 2 = day 4-6)date_rangeTime Frame:baseline and over 3-daysenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3date_rangeTime Frame:1 dayenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:6 daysenhanced_encryptionNoSafety Issue:
- Pharmacokinetics: Cmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)date_rangeTime Frame:6 daysenhanced_encryptionNoSafety Issue:
- Pharmacokinetics: tmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)date_rangeTime Frame:6 daysenhanced_encryptionNoSafety Issue:
- Pharmacokinetics: Cmax,md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)date_rangeTime Frame:6 daysenhanced_encryptionNoSafety Issue:
- Pharmacokinetics: AUC(0-tlast)md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)date_rangeTime Frame:6 daysenhanced_encryptionNoSafety Issue:
- Pharmacokinetics: t1/2,md of lanthanum in plasmafrom pre-administration (Day 4) to 48 hours after the last administration (Day 6)date_rangeTime Frame:6 daysenhanced_encryptionNoSafety Issue:
- Number of adverse events as a measure of safety and tolarabilitydate_rangeTime 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)enhanced_encryptionYesSafety Issue:
- Pharmacokinetics: AUC(0-tlast)md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)date_rangeTime Frame:6 daysenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2