Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet

Clinical Pharmacology Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074058
• Other study ID #: 18060
• Status: Completed
• Phase: Phase 1
• First received: March 3, 2017
• Last updated: March 20, 2017
• Start date: June 10, 2015
• Est. completion date: August 21, 2015

Study information

• Verified date: March 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 21, 2015
• Est. primary completion date: August 4, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Clinical Pharmacology

Intervention

Drug:
• Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)
Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID
• Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)
Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pharmacodynamics: Daily urinary phosphate excretion (mmol) on Day 3		1 day
Secondary	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.	6 days
Secondary	Pharmacokinetics: Cmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)		6 days
Secondary	Pharmacokinetics: tmax,md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)		6 days
Secondary	Pharmacokinetics: Cmax,md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)		6 days
Secondary	Pharmacokinetics: AUC(0-tlast)md,norm of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)		6 days
Secondary	Pharmacokinetics: t1/2,md of lanthanum in plasmafrom pre-administration (Day 4) to 48 hours after the last administration (Day 6)		6 days
Secondary	Number of adverse events as a measure of safety and tolarability		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)
Secondary	Pharmacokinetics: AUC(0-tlast)md of lanthanum in plasma from pre-administration (Day 4) to 48 hours after the last administration (Day 6)		6 days

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