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Moksi

Phase 1

Bioequivalence | Small molecule | Other |Abbott Laboratories|Last Updated: Apr 1, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment38

FDA Designations

No designations recorded

Clinical trial landscape

Moksi · 1 trial · 1 indication

Phase 1 1
NCT05307614Bioequivalence Study of Moksi® 400mg Tablet and Avelox® 400mg Tablet (Moxifloxacin) Under Fasting Condition in Healthy Adult Pakistani SubjectsBioequivalence
COMPLETED38 Analytics
PHASE1COMPLETED
Bioequivalence Study of Moksi® 400mg Tablet and Avelox® 400mg Tablet (Moxifloxacin) Under Fasting Condition in Healthy Adult Pakistani Subjects
BioequivalenceUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax
0-72 hours post dose

maximum plasma concentration of Moxifloxacin

AUC last (AUC 0-t)
0-72 hours post dose

Area under plasma concentration time curve from zero to time of the last measurable concentration

AUC total (AUC 0-∞)
0-72 hours post dose

area under the plasma concentration-time curve from zero to infinity.

Secondary Endpoints

Tmax
0-72 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Moksi® 400mg Tablet of AbbottEXPERIMENTALHealthy subjects were orally administered a single dose of Moksi® 400mg Tablet (Moxifloxacin) under fasting condition
Avelox® 400mg Tablet of BayerACTIVE_COMPARATORHealthy subjects were orally administered a single dose of Avelox® 400mg Tablet (Moxifloxacin) under fasting condition.

Interventions

NameTypeDescription
Moksi® 400mg TabletDRUGSingle dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.
Drug: Avelox® 400Mg TabletDRUGSingle dose of Moxifloxacin 400 mg Tablet was administered after a 10-hour overnight fast.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male volunteers aged 18 to 55 years inclusive. 2. Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive). 3. Subjects who are healthy as determined by routine physical examination,including vital sign monitoring (ie, blood pressure, heart rate,and temp...

Countries:Pakistan
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Frequently asked questions about Moksi

What is Moksi used for?

Moksi is a small molecule drug being developed by Abbott Laboratories for bioequivalence. It is being studied as a 400mg tablet formulation to compare with Avelox 400mg tablet (moxifloxacin) under fasting conditions in healthy adult subjects. The drug is currently in Phase 1 clinical development.

Who makes Moksi?

Moksi is being developed by Abbott Laboratories, a company traded on the stock exchange under the ticker ABT. The drug is currently in Phase 1 clinical development for bioequivalence purposes.

What phase is Moksi in?

Moksi is in Phase 1 clinical development. It is an investigational drug being studied for bioequivalence. A Phase 1 clinical trial has been completed to evaluate its bioequivalence compared to Avelox 400mg tablet (moxifloxacin) under fasting conditions.

What clinical trials is Moksi in?

Moksi has one completed clinical trial registered under NCT05307614. This Phase 1 study evaluated the bioequivalence of Moksi 400mg tablet and Avelox 400mg tablet (moxifloxacin) under fasting conditions in healthy adult Pakistani subjects. The trial enrolled 38 male participants.

Is Moksi FDA approved?

Moksi is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied for bioequivalence, and a Phase 1 clinical trial has been completed, but it has not yet received regulatory approval.