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Myrin 2

Phase 1

Tuberculosis | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Jul 30, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

Myrin 2 · 1 trial · 1 indication

Phase 1 1
NCT01311505Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)Tuberculosis
COMPLETED21 Analytics
PHASE1COMPLETED
Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)
TuberculosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC [0-t])
0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hours (hrs) post-dose

AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

Maximum Observed Plasma Concentration (Cmax)
0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose

Secondary Endpoints

Time to Reach Maximum Observed Plasma Concentration (Tmax)
0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])
0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose
Plasma Decay Half-life (t1/2)
0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATORTest
BACTIVE_COMPARATORReference

Interventions

NameTypeDescription
Myrin© 2 (Rifampicin + Isoniazid)DRUGTwo (2) fixed-dose combination tablets each containing Rifampicin 150 mg and Isoniazid 75 mg
Rimactane® (Rifampicin)DRUGOne (1) capsule of Rifampicin 300 mg
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects between the ages of 18 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * An informed consent document signed and dated by the subject. * Subjects willing and able to comply with scheduled ...

Countries:Philippines
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Competitive Landscape -Tuberculosis 7 trials

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Frequently asked questions about Myrin 2

What is Myrin 2 used for?

Myrin 2 is a small molecule being developed by Pfizer, Inc. for the treatment of tuberculosis. It is currently in Phase 1 clinical development as an investigational drug. The drug is being studied in the infectious disease therapeutic area.

Who makes Myrin 2?

Myrin 2 is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company is conducting clinical research on this investigational small molecule for tuberculosis.

What phase is Myrin 2 in?

Myrin 2 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of tuberculosis.

What clinical trials is Myrin 2 in?

Myrin 2 has one completed Phase 1 clinical trial, identified as NCT01311505. This was a bioequivalence study comparing a fixed-dose combination of rifampicin and isoniazid (Myrin 2) against the reference drug rifampicin (Rimactane). The trial enrolled 21 healthy male volunteers in the Philippines.

Is Myrin 2 the same as a fixed-dose combination?

Yes, Myrin 2 is a fixed-dose combination containing rifampicin and isoniazid. It was studied in a bioequivalence trial comparing it to the reference drug rifampicin (Rimactane) to assess how the combination performs relative to the single reference drug.