A Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of Sustained Release(SR) Exenatide

Peptron

Status and phase

Completed

Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: SR Exenatide (PT302)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

PepE01

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of SR exenatide (PT302) in healthy subjects.

Enrollment

34 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Exclusion criteria

Has a present illness or medical history of hepatic, renal, respiratory, cardiovascular disease, blood tumor, mental disorder, and endocrinologic disorder, especially diabetes mellitus
Has a sign or symptom or history related to an acute or chronic pancreatitis
Has a known allergy or hypersensitivity to exenatide or other drugs such as aspirin, antibiotics, and so on
Has ever been exposed to exenatide
Shows SBP >= 150 mmHg or <= 90 mmHg or DBP >= 100 mmHg or <= 50 mmHg
Has a presence or history of drug abuse
Uses any prescription drug, herbal medicine within 2 weeks or OTC drugs or vitamin within 1 week prior to study drug administration
Has been participated in other clinical trial within 2 months
Has experience of a blood donation during 2 months or a blood transfusion during 1 month prior to study drug administration
Heavy smoker more than 10 cigarettes/day within 3 months prior to screening
Continuous drinker (over 21 units/week, 1 unit = 10 g of pure alcohol) or subject who can't quit drinking nor smoking during clinical trial period
Subjects not eligible at the discretion of investigators