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MEDI0382 Formulation 2

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Feb 14, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

MEDI0382 Formulation 2 · 1 trial · 1 indication

Phase 1 1
NCT03341013A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382Type 2 Diabetes Mellitus
COMPLETED24 Analytics
PHASE1COMPLETED
A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under the drug concentration curve
48 hours

To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382

Maximum observed plasma concentration of MEDI0382
48 hours

To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382.

Secondary Endpoints

Area under the plasma drug concentration versus time curve from zero to infinity and to last observation
48 hours
Time to maximum observed plasma drug concentration
48 hours
Terminal phase elimination half-life
48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTALformulation 2 on Day 1 and formulation 3 on Day 10
Sequence 2EXPERIMENTALformulation 3 on Day 1 and formulation 2 on Day 10

Interventions

NameTypeDescription
MEDI0382 Formulation 2DRUGSequence 1 Period 1 and Sequence 2 Period 2.
MEDI0382 Formulation 3DRUGSequence 1 Period 2 and Sequence 2 Period 1
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy subjects age 18 through 45 years at the time of screening. 2. Provision of signed and dated written informed consent prior to study-specific procedures. 3. Body mass index between 19 and 30 kg/m2 (inclusive) at screening 4. Good general health as judged by the investi...

Countries:United States
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Frequently asked questions about MEDI0382 Formulation 2

What is MEDI0382 Formulation 2 used for?

MEDI0382 Formulation 2 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development, with one completed trial in the United States. The drug is not yet approved and remains under investigation.

Who makes MEDI0382 Formulation 2?

MEDI0382 Formulation 2 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate this investigational drug for Type 2 Diabetes Mellitus.

What phase is MEDI0382 Formulation 2 in?

MEDI0382 Formulation 2 is in Phase 1 clinical development. One Phase 1 trial has been completed, involving 24 participants in the United States. The drug is investigational and has not received regulatory approval for any use.

What clinical trials is MEDI0382 Formulation 2 in?

MEDI0382 Formulation 2 has one completed clinical trial, identified as NCT03341013. This Phase 1 study investigated bioequivalence between a single dose of Formulation 2 and Formulation 3 of MEDI0382 in healthy volunteers with Type 2 Diabetes Mellitus.

Is MEDI0382 Formulation 2 the same as MEDI0382?

MEDI0382 Formulation 2 is a specific formulation of the drug MEDI0382. The clinical trial NCT03341013 compared this formulation with Formulation 3 of the same drug. Both formulations are being evaluated for the treatment of Type 2 Diabetes Mellitus.