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Myrin 2

Phase 1

Tuberculosis | Small molecule | Infectious Disease |Pfizer, Inc.|Trials 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

Myrin 2 clinical trials

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 17 trials

Top 2 of 3 competitors

CompanyTickerTrialsLead PhaseDrugs
BioNTech SE Sponsored ADRBNTX1PHASE1BNT164a1, BNT164b1
GSK plc Sponsored ADRGSK1PHASE1Ganfeborole
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Frequently asked questions about Myrin 2

What is Myrin 2 used for?

Myrin 2 is a fixed-dose combination of rifampicin and isoniazid developed for the treatment of tuberculosis. It is a small-molecule anti-infective product. The only clinical study of Myrin 2 on record was a Phase 1 bioequivalence study conducted in healthy adult male volunteers in the Philippines.

Who makes Myrin 2?

Myrin 2 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor associated with the fixed-dose combination product containing rifampicin and isoniazid.

What phase is Myrin 2 in?

Myrin 2 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study was an active-controlled, randomized bioequivalence study, and it was not double blinded. Myrin 2 is investigational and is not described as approved.

What clinical trial has been conducted for Myrin 2?

Myrin 2 has been studied in one completed Phase 1 trial, NCT01311505. That trial was a bioequivalence study comparing the rifampicin component in the fixed-dose combination Myrin 2 with the reference drug Rimactane, a stand-alone rifampicin product. It enrolled 21 healthy adult male volunteers in the Philippines.