Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT01620333
Eligibility Criteria:
Inclusion Criteria:
* Healthy
* Japanese
* Body Mass Index (BMI) of 19-27 kg/m\^2 (both inclusive)
* Fasting blood glucose between 3.8-6 mmol/L (68.4-108.0 mg/dL) (both inclusive
* Considered generally healthy upon completion of medical history and physical examination, as judged by the Investigator or Sub-Investigator
Exclusion Criteria:
* Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator or Sub-Investigator(s)
* Any serious systemic infectious disease that occurred during the 4 weeks prior to the screening, as judged by the Investigator or Sub-Investigator
* Any inter-current illness that may affect blood glucose, as judged by the Investigator or Sub-Investigator
* Hepatitis B or C, or HIV (human immunodeficiency virus)
* Use of prescription drugs within 2 weeks preceding the screening
* Use of non-prescription drugs, except routine vitamins or drugs that may not
* Blood donation of more than 1150 mL within the last 12 months
* Subjects with a first degree relative with diabetes mellitus
* History of or presence of diabetes
* History of or presence of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematologic, neurologic, or psychiatric diseases or disorder
* Previous history of serious allergy or anaphylactic reaction
* Subjects who consume more than 28 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse
* Subjects who smoke more than 5 cigarettes per day
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT01620333
Study Brief:
Protocol Section:
NCT01620333