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Cortiment

Phase 1

Undisclosed | Small molecule | Other |Abbott Laboratories|Trials Updated: Aug 29, 2022

Cortiment development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Cortiment clinical trials

Cortiment · 1 trial · 4 indications

Phase 1 1
NCT05519514Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult SubjectsHealthy Subjects
COMPLETED56 Analytics
PHASE1COMPLETED
Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence of Test Product (T) Vs Reference Product (R) Pharmacokinetic parameters: Cmax (Maximum plasma concentration)
Till 72 hours post dose after each dosing

Cmax (Maximum plasma concentration)

Bioequivalence of Test Product (T) Vs Reference Product (R) Pharmacokinetic Parameters: AUC0-t (area under the curve)
Till 72 hours post dose after each dosing

AUC0-t (area under the curve)

Secondary Endpoints

Safety and tolerability of Test Product (T) and the Reference Product (R) Serious adverse events
Till 30 days since last dosing period
Safety and tolerability of Test Product (T) and the Reference Product (R) Systolic and diastolic blood pressure
Till 72 hours post dose after each dosing
Safety and tolerability of Test Product (T) and the Reference Product (R) Pulse rate
Till 72 hours post dose after each dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cortiment (Budesonide 9 mg prolonged release tablet)ACTIVE_COMPARATOR -
Budesonide 9 mg prolonged release tabletEXPERIMENTAL -

Interventions

NameTypeDescription
CortimentDRUGBudesonide 9 mg prolonged release tablets
BudesonideDRUGExperimental (Budesonide 9 mg prolonged release tablets)
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Normal healthy human adult male and non- pregnant female volunteers between 18-45 years (both ages inclusive) of age. 2. Who is given written informed consent and are willing to participate in the study. 3. Body Mass Index of 18.50 to 30.00 Kg/m2 (both inclusive). 4. No evide...

Countries:India
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Frequently asked questions about Cortiment

What is Cortiment?

Cortiment is an investigational small molecule drug being developed by Abbott Laboratories. It is a prolonged-release tablet formulation of budesonide. Abbott is listed under the ticker ABT. The drug is in Phase 1 clinical development, and the specific therapeutic indication has not been disclosed.

Who makes Cortiment?

Cortiment is being developed by Abbott Laboratories, which trades under the ticker symbol ABT. Abbott is the sponsor of the clinical program for this drug candidate.

What phase is Cortiment in?

Cortiment is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA.

What clinical trials is Cortiment in?

Cortiment has been studied in one completed Phase 1 trial, NCT05519514, titled Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects. The trial enrolled 56 healthy adult participants in India and was active-controlled and randomized.

Is Cortiment the same as budesonide?

Cortiment is a prolonged-release tablet formulation containing budesonide as the active ingredient. It is not a different drug substance but a specific oral formulation of budesonide developed by Abbott Laboratories.