An open-label, one-period, parallel-group, single administration study to evaluate the pharmacokinetic/pharmacodynamic profile of zolpidem 10 mg in healthy Korean male and female volunteers

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1) Healthy male and female volunteers age between 20 - 45 years
2) Weight between 50 - 100 kg and BMI result between 17 - 30.
3) Suitable to participate the study based on the result of physical examination, lab result and etc.
4) The subject fully understood the study and decided to participate the study voluntarily.

Exclusion Criteria

1) History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
A. A person with pulmonary sleep apnea or past history
B. A person with severe work history
C. A person with severe liver failure or past history
D. A person with acute or severe respiratory failure or past history
E. A person with severe liver failure, cirrhosis or bile retention, or past history
2) Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the trial medication (except appendectomy and simple hernia repair).
3) Subjects with a history of clinically significant hypersensitivity to food and other drugs (such as aspirin and non-steroidal anti-inflammatory drugs, antibiotics, etc.) that contain medicines for clinical trials or the same family of ingredients
4) Subjects showed the results below
? Blood AST (SGOT) and ALT (SGPT) above the upper normal range limit of 1.5 times
? ECG QTc > 450 ms or clinically significant rhythm
5) A person whose vital signs are measured at the left after a three-minute break at the time of the screening test showed the figure included in any of the following criteria:
A. Systolic blood pressure: < 90 mmHg or > 150 mmHg
B. Expander blood pressure: < 50 mmHg or > 100 mmHg
C. Pulse rate: > 100/minute or 54 times/minute
6) History of drug or a positive test for alcohol or drugs of abuse, such as cotinine,amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates at screening.
7) any of the following criteria are included in the contraception and pregnancy related items
A
(*The following methods of contraception are clinically acceptable in this test: Physical blocking method used in combination with endometrial devices (such as loops), chemical blocking method (deafs), partner infertility, and abstinence
B. A person willing to use a hormone preparation or a hormone release device (mirena, implanon, etc.) during the clinical trial period
C. A fertile woman identified as 'positive' after pregnancy test
D. A person who does not agree with the contraceptive method given in paragraph 7.A) for men without vasectomy or who plans to donate sperm during the test
8) Regular treatment with nonprescription medications. Subjects should have ended any nonprescription medications at least 10 days before the first dosing of the study drug. Potential subjects should consult a physician before stopping any regular treatment with nonprescription medication.
9) Participation in a clinical study involving administration of either an investigational or a marketed drug within 3 months before screening.
10) Blood donation or a significant loss of blood within 60 days of the start of study drug dosing or donation of more than 1 unit of plasma within 7 days before screening.
11) Regular consumption of more than 21 units of alcoholic beverages per week before screening. Subjects may not consume any alcohol during study period.
12) Smokers (But if subjects did not smoke for 3 months before first doing can be participated in study)
13) A person who ingests grapefruit (Jamong)/caffeinated food within 3 days of the first dose
14) A person who took a drug-induced and inhibiting drug, such as a barbitrary drug, within one month prior to the commencement of the test
15) Persons with unusual eating habits (e.g. continuous vegetarian diet, e