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RIN 150

Phase 1

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

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

Clinical trial landscape

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 Volunteers
NCT0201427228
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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 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 used for?

RIN 150 is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to compare a fixed dose combination formulation of RIN 150 with individual reference drugs. The study is not intended to treat a specific disease but to assess bioequivalence in healthy participants.

Who makes RIN 150?

RIN 150 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting a Phase 1 clinical trial of RIN 150 in healthy volunteers to evaluate the bioequivalence of a fixed dose combination formulation compared to individual reference drugs.

What phase is RIN 150 in?

RIN 150 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial, which is now completed, enrolled 28 healthy volunteers in Singapore to assess the bioequivalence of a fixed dose combination formulation of RIN 150.

What clinical trials is RIN 150 in?

RIN 150 has one completed Phase 1 clinical trial, identified as NCT02014272. The trial, titled "A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers," enrolled 28 participants in Singapore. The study was active-controlled and randomized, though not double-blinded.

Is RIN 150 the same as a fixed dose combination?

RIN 150 is being studied as a fixed dose combination formulation. The Phase 1 clinical trial compares this formulation to individual reference drugs to determine bioequivalence. The study is designed to assess whether the combination product delivers the same drug exposure as the separate components.