CompletedNot Applicable

Pharmacokinetics Study of Gamma-aminobutyric Acid

China12 participantsStarted 2013-07

Plain-language 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, serum C-peptide and/or insulin levels (referred to as pharmacokinetics/pharmacodynamics). We will conduct experiments in normal subjects to address these questions.

Who can participate

Age range19 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

pharmacokinetic characteristics of γ-aminobutyric acid (GABA)

Timeframe: baseline and up to 30 days

Trial details

NCT IDNCT01917760

SponsorHuashan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-07

View on ClinicalTrials.gov More Diabetes Mellitus trials