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Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet

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ClinicalTrials.gov Identifier: NCT03074058
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Clinical Pharmacology Drug: Fosrenol ODT (Lanthanum Carbonate, BAY77-1931) Drug: Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 10, 2015
Actual Primary Completion Date : August 4, 2015
Actual Study Completion Date : August 21, 2015

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Arm Intervention/treatment
Experimental: Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)
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 orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074058


Locations
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Japan
Fukuoka, Japan, 812-0025
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03074058     History of Changes
Other Study ID Numbers: 18060
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017