Diabetes Mellitus Clinical Trial
— GABA-PKOfficial title:
The Pharmacokinetics of Gamma-aminobutyric Acid in Healthy Volunteers.
Verified date | October 2015 |
Source | Huashan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Observational |
The purpose of this study is to determine upon administering GABA orally to a person how it is absorbed, distributed, as well as the drug's pharmacological effects on the body such as glucose levels, serum C-peptide and/or insulin levels (referred to as pharmacokinetics/pharmacodynamics). We will conduct experiments in normal subjects to address these questions.
Status | Completed |
Enrollment | 12 |
Est. completion date | December 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 40 Years |
Eligibility |
Inclusion Criteria: 1. Volunteers in good health condition between 19 and 40 years of age (inclusive) at the time of signing the informed consent. 2. Body mass index (BMI) between 18.5 and 24 kg/m2 (inclusive), with weight greater than 50 kg. 3. Not on any medication 2 weeks before screening. 4. No blood donation within 3 months before screening. 5. Must sign the informed consent. Note: Blood and biochemical tests must be normal during the screening. However, if the participant's test-results were beyond the normal range, the individual can still be recruited as long as the results do not affect the experiment. Exclusion Criteria: 1. Abnormalities of physical examination, laboratory tests, or ECG in screening, which may influence the results of the study. 2. Previous or existing history of severe heart, liver, kidney, gastrointestinal, nervous system, mental, or metabolic abnormalities as well as other diseases which can affect drug absorption, circulation, metabolism, or excretion. 3. History of alcoholism, smoking, or drug abuse within the past 1 year. 4. Participation in any clinical drug study within the past 30 days. 5. Any definite or suspected allergy or family history of allergy to GABA or any other similar drugs. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Department of Endocrinology and Metabolism,Huashan hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital | St. Michael's Hospital, Toronto, University of Florida, University of Massachusetts, Worcester |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory measures | plasma glucagon-like peptide-1 (GLP-1) and glycated serum protein (GSP)will be measured. | baseline and up to 30 days | No |
Primary | pharmacokinetic characteristics of ?-aminobutyric acid (GABA) | The primary endpoint of this study is to obtain the pharmacokinetic characteristics of ?-aminobutyric acid (GABA), including: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t), Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-8), Maximum observed plasma concentration (Cmax), Time to maximum plasma concentration (Tmax), and Terminal elimination half-life in plasma (t½) |
baseline and up to 30 days | No |
Secondary | serological characteristics | plasma glucose levels, insulin, C-peptide and glucagon levels will be measured | baseline and up to 30 days | No |
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