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Cortiment

Phase 1

Healthy Subjects | Small molecule | Other |Abbott Laboratories|Last Updated: Aug 29, 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

Clinical trial landscape

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 used for?

Cortiment is a small molecule drug being developed by Abbott Laboratories for use in healthy subjects. It is currently in Phase 1 clinical development, with studies focused on bioequivalence in healthy human adult volunteers. The drug is not approved and remains investigational.

Who makes Cortiment?

Cortiment is being developed by Abbott Laboratories, a company traded under the ticker ABT. The drug is currently in Phase 1 clinical development for use in healthy subjects.

What phase is Cortiment in?

Cortiment is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a bioequivalence study in healthy human adult subjects. The drug is investigational and not yet approved.

What clinical trials is Cortiment in?

Cortiment has one completed Phase 1 clinical trial, NCT05519514, titled 'Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects.' The trial enrolled 56 participants in India and was active-controlled, though not double-blinded.

Is Cortiment the same as budesonide?

Cortiment is being studied as a budesonide prolonged-release tablet. The Phase 1 trial NCT05519514 evaluated the bioequivalence of Cortiment 9 mg tablets in healthy subjects, indicating the drug's active ingredient is budesonide.