Status:
COMPLETED
Pharmacokinetics Study of Gamma-aminobutyric Acid
Lead Sponsor:
Huashan Hospital
Collaborating Sponsors:
Unity Health Toronto
University of Florida
Conditions:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Eligibility:
All Genders
19-40 years
Brief Summary
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, ...
Detailed Description
Type 1 diabetes is an autoimmune disease resulting from the progressive loss of pancreatic insulin-secreting beta-cells. This consequently leads to a lack of insulin and elevation of blood sugar, name...
Eligibility Criteria
Inclusion
- Volunteers in good health condition between 19 and 40 years of age (inclusive) at the time of signing the informed consent.
- Body mass index (BMI) between 18.5 and 24 kg/m2 (inclusive), with weight greater than 50 kg.
- Not on any medication 2 weeks before screening.
- No blood donation within 3 months before screening.
- 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
- Abnormalities of physical examination, laboratory tests, or ECG in screening, which may influence the results of the study.
- 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.
- History of alcoholism, smoking, or drug abuse within the past 1 year.
- Participation in any clinical drug study within the past 30 days.
- Any definite or suspected allergy or family history of allergy to GABA or any other similar drugs.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01917760
Start Date
July 1 2013
End Date
December 1 2014
Last Update
November 2 2015
Active Locations (1)
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1
Department of Endocrinology and Metabolism，Huashan hospital
Shanghai, Shanghai Municipality, China, 200040