check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

18060

ClinicalTrials.gov Identifier:

NCT03074058

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

Male

Age

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

  • - 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)

Trial summary

Enrollment Goal
20
Trial Dates
June 2015 - August 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Fukuoka, 812-0025, Japan

Primary Outcome

  • 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.
    date_rangeTime Frame:
    6 days
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    baseline and over 3-days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3
    date_rangeTime Frame:
    1 day
    enhanced_encryption
    Safety Issue:
    No
  • 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 days
    enhanced_encryption
    Safety Issue:
    No
  • 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 days
    enhanced_encryption
    Safety Issue:
    No
  • 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 days
    enhanced_encryption
    Safety Issue:
    No
  • 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 days
    enhanced_encryption
    Safety Issue:
    No
  • 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 days
    enhanced_encryption
    Safety Issue:
    No
  • 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 days
    enhanced_encryption
    Safety Issue:
    No
  • Number of adverse events as a measure of safety and tolarability
    date_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_encryption
    Safety Issue:
    Yes
  • 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 days
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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