Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet

NCT03074058 | Completed Phase 1

• 1 other identifier: 18060
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Pharmacology

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  baseline and over 3-days

Secondary Outcomes (9)

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

  1 day

• Plasma lanthanum concentrations (ng/mL)

  6 days

• Pharmacokinetics: Cmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)

  6 days

• Pharmacokinetics: tmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)

  6 days

• Pharmacokinetics: Cmax,md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)

  6 days

Study Arms (2)

Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)

EXPERIMENTAL

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 chewable Tablet (Lanthanum Carbonate, BAY77-1931)

ACTIVE COMPARATOR

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)

Interventions

Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) DRUG

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

Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)

Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) DRUG

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

Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Fukuoka, Fukuoka, 812-0025, Japan

Location

MeSH Terms

Interventions

lanthanum carbonate

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: June 10, 2015
• Primary Completion: August 4, 2015
• Study Completion: August 21, 2015
• Last Updated: March 21, 2017

Record last verified: 2017-03

Locations

JP (1)