Clinical trial NCT03074058: Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet
Official title: Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet - Randomized, Open-label, Two-way Crossover Study to Establish the Bioequivalence Between BAY 77-1931 Orally Disintegrating Tablet 500 mg and Fosrenol Chewable Tablet 500 mg Administered in Japanese Healthy Male Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clinical Pharmacology
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-03-08
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Japanese healthy male adult volunteers (age, 20-45 years; BMI, 17.6-26.4 kg/m2)

Exclusion Criteria:

* Regular use of medicines including Chinese herbal drugs
* Clinically relevant findings in the physical examination
* Subject who cannot take the study drug appropriately (e.g. weak biting force, insufficient salivary flow)

Primary outcomes:
measure: Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each day
timeFrame: 6 days
measure: Bioequivalence: Average of daily urinary phosphate excretion (mmol) over 3-day dosing period
timeFrame: baseline and over 3-days
Secondary outcomes:
measure: Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3
timeFrame: 1 day
measure: Plasma lanthanum concentrations (ng/mL)
timeFrame: 6 days
measure: Pharmacokinetics: Cmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
timeFrame: 6 days
measure: Pharmacokinetics: tmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
timeFrame: 6 days
measure: Pharmacokinetics: Cmax,md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
timeFrame: 6 days
measure: Pharmacokinetics: AUC(0-tlast)md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
timeFrame: 6 days
measure: Pharmacokinetics: t1/2,md of lanthanum in plasmafrom pre-administration (Day 4) to 48 hours after the last administration (Day 6)
timeFrame: 6 days
measure: Number of adverse events as a measure of safety and tolarability
timeFrame: 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)
measure: Pharmacokinetics: AUC(0-tlast)md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)
timeFrame: 6 days
Other outcomes:
Locations:
city: Fukuoka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: