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RIN 150

Phase 1

Healthy Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 16, 2014

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_CONTROLLED
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02014272A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy VolunteersPHASE1 COMPLETED 28 — — Sep 1, 2012Oct 1, 2012Jul 16, 20141 Singapore
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Study Endpoints
Primary Endpoints
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) was reported for rifampicin and isoniazid.

Maximum Observed Plasma Concentration (Cmax)
0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1

Cmax was reported for rifampicin and isoniazid.

Secondary Endpoints
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1
Plasma Decay Half-Life (t1/2)
0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
TestEXPERIMENTALRIN 150 contains 150 rifampicin and 75 mg isoniazid
ReferenceACTIVE_COMPARATORIndividual references of rifampicin and isoniazid
Interventions
NameTypeDescription
RIN 150DRUGEach subject will receive a single oral dose of 4 fixed dose combination tablets (RIN 150) each contains 150 rifampicin and 75 mg isoniazid.
reference drugsDRUGEach subject will receive a single oral dose of 4 x 150 mg rifampicin capsules and 3 x 100 mg isoniazid capsules.
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Eligibility Criteria
Age Range21 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female, 21 to 55 years of age, body weight no less than 55 kg, with a signed and dated informed consent document and is willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: * Ev...

Countries:Singapore
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