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NCT Number: NCT03074058

Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet

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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Key information

Conditions

Clinical Pharmacology

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fukuoka, 812-0025, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)

Drug

Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID

Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)

Drug

Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID

Primary outcomes

  1. Pharmacodynamics: Daily urinary phosphate excretion (mmol) on each day

    Time frame: 6 days

    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.

  2. Bioequivalence: Average of daily urinary phosphate excretion (mmol) over 3-day dosing period

    Time frame: baseline and over 3-days

    During lanthanum carbonate TID treatment period over 3 days in each period (period 1 = day 1-3; period 2 = day 4-6)

Secondary outcomes

  1. Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3

    Time frame: 1 day

  2. Plasma lanthanum concentrations (ng/mL)

    Time frame: 6 days

    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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 8, 2017
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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