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Ibandronate

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jun 28, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Ibandronate · 1 trial · 1 indication

Phase 1 1
NCT01627886Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting ConditionHealthy
COMPLETED100 Analytics
PHASE1COMPLETED
Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition
Healthy
NCT01627886100
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Study Endpoints

Primary Endpoints

Area under curve(AUC)
Prior to dosing (0.0 hour) and at 0.25, 0.50, 0.75, 1.0, 1.25, 1.50, 2.0, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 24.0, 36.0, 48.0 and 72.0 hours post dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ibandronate sodium tablets 150 mgEXPERIMENTALIbandronate sodium tablets 150 mg of Dr. Reddy's Laboratories Limited
BonivaACTIVE_COMPARATORBoniva Tablets 150 mg of Roche Laboratories Inc, USA

Interventions

NameTypeDescription
Ibandronate sodiumDRUGIbandronate sodium Tablets 150 mg
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Eligibility Criteria

Age Range19 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. The subjects should be healthy human of 18 years or older. 2. The subjects should be screened within 21 days prior to the administration of first dose of the study drug. 3. The subjects should have a BMI between 19 and 30 weight in kg/ height2 in meter. 4. The subjects should...

Countries:India
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Frequently asked questions about Ibandronate

What is Ibandronate used for?

Ibandronate is a small molecule being studied in healthy volunteers. The clinical trial for Ibandronate is a bioequivalence study of Ibandronate Sodium Tablets 150 mg under fasting conditions. It is currently in Phase 1 clinical development.

Who makes Ibandronate?

Ibandronate is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting clinical trials for this small molecule drug.

What phase is Ibandronate in?

Ibandronate is in Phase 1 clinical development. The completed trial, NCT01627886, was a Phase 1 bioequivalence study. Ibandronate is an investigational drug and is not approved for any indication.

What clinical trials is Ibandronate in?

Ibandronate has one clinical trial, NCT01627886, titled 'Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition'. This Phase 1 trial was completed in India with 100 healthy volunteers, including both males and females aged 19 years and older.

Is Ibandronate the same as Ibandronate Sodium?

Ibandronate is the active ingredient in Ibandronate Sodium tablets. The clinical trial for Ibandronate specifically studied Ibandronate Sodium Tablets 150 mg, indicating that Ibandronate Sodium is the salt form of the drug being tested.