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RIN 150

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Jul 16, 2014

RIN 150 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

RIN 150 clinical trials

RIN 150 · 1 trial · 1 indication

Phase 1 1
NCT02014272A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy VolunteersHealthy Volunteers
COMPLETED28 Analytics
PHASE1COMPLETED
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers
Healthy VolunteersUnlock trial analytics

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 to 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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Frequently asked questions about RIN 150

What is RIN 150?

RIN 150 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It has been studied in a Phase 1 bioequivalence trial comparing a fixed dose combination formulation with RIN 150 and individual reference drugs in healthy volunteers. The specific therapeutic indication for RIN 150 has not been disclosed.

Who makes RIN 150?

RIN 150 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 bioequivalence study of RIN 150 conducted in Singapore.

What phase is RIN 150 in?

RIN 150 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study was an active-controlled, randomized bioequivalence trial in healthy volunteers.

What clinical trials is RIN 150 in?

RIN 150 has been evaluated in one completed Phase 1 trial, NCT02014272, titled a bioequivalence study comparing a fixed dose combination formulation, RIN 150 and individual reference drugs in healthy volunteers. The trial enrolled 28 participants in Singapore and was active-controlled and randomized.

What was the design of the RIN 150 bioequivalence trial?

The RIN 150 bioequivalence trial, NCT02014272, was a Phase 1, randomized, active-controlled study in healthy volunteers aged 21 years and older of all sexes. It enrolled 28 participants in Singapore and compared a fixed dose combination formulation with RIN 150 and individual reference drugs. The study is completed.