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Lanthanum Carbonate Granule

Phase 1

Hyperphosphatemia | Small molecule | Nephrology |Bayer AG|Last Updated: Jun 23, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment59

FDA Designations

No designations recorded

Clinical trial landscape

Lanthanum Carbonate Granule · 1 trial · 1 indication

Phase 1 1
NCT01053676Bioequivalence Study of BAY77-1931 GranuleHyperphosphatemia
COMPLETED59 Analytics
PHASE1COMPLETED
Bioequivalence Study of BAY77-1931 Granule
HyperphosphatemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on daily urinary phosphate excretion
Follow up examination cunducted on 7 to 10 days after the last drug administration

Secondary Endpoints

Adverse event collection
Follow up examination cunducted on 7 to 10 days after the last drug administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Lanthanum Carbonate (Fosrenol, BAY77-1931) GranuleDRUGBAY77-1931 Granule TID for 4 days
Lanthanum Carbonate (Fosrenol, BAY77-1931) Chewable tabletDRUGBAY77-1931 Chewable tablet TID for 4 days
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Japanese male volunteers who must have given their written informed consent to participate in the study * Age is between 20 and 45 years * Body Mass Index (BMI) is between 17.6 and 26.4 kg/m2. * Volunteers who are judged by the investigators to be suitable for enrollment in th...

Countries:Japan
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Frequently asked questions about Lanthanum Carbonate Granule

What is Lanthanum Carbonate Granule used for?

Lanthanum Carbonate Granule is used for hyperphosphatemia, a condition of elevated phosphate levels in the blood. It is being developed by Bayer AG as a small molecule therapy in the nephrology therapeutic area. The drug is currently in Phase 1 clinical development.

Who makes Lanthanum Carbonate Granule?

Lanthanum Carbonate Granule is being developed by Bayer AG, which trades under the ticker BAYRY. The company is conducting clinical trials for this drug in the treatment of hyperphosphatemia. The drug is currently in Phase 1 development.

What phase is Lanthanum Carbonate Granule in?

Lanthanum Carbonate Granule is in Phase 1 clinical development. It is an investigational drug being studied for hyperphosphatemia. One Phase 1 trial has been completed, and the drug is not yet approved for any use.

What clinical trials is Lanthanum Carbonate Granule in?

Lanthanum Carbonate Granule has one completed clinical trial, NCT01053676, titled "Bioequivalence Study of BAY77-1931 Granule." This Phase 1 study enrolled 59 healthy male volunteers in Japan, aged 20 years and older, and was active-controlled but not double-blinded.

Is Lanthanum Carbonate Granule the same as BAY77-1931?

Yes, Lanthanum Carbonate Granule is also known as BAY77-1931. The clinical trial NCT01053676, which studied this drug, is titled "Bioequivalence Study of BAY77-1931 Granule," confirming that BAY77-1931 is the same drug as Lanthanum Carbonate Granule.