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Ibandronate

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01627886Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting ConditionPHASE1 COMPLETED 100 — — Sep 1, 2008Oct 1, 2008Jun 28, 20121 India
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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 — 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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