Diabetic Mellitus
Conditions
Interventions
Case series:nateglinide (2 tablets of 30 mg each)
Sponsors
The Clinical Pharmacology Laboratory of Nanjing First Hospital
Eligibility
Sex/Gender
Male
Age
20 Years to 27 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese male subjects, 18 to 30 years of age, Body weight between +/-10%standard body weight, BMI 19 to 25 kg/m2; 2. A healthy status confirmed by medical documentation (complete medical history, physical;examination, chest radiography, serum laboratory evaluation, and electrocardiography); 3. Nonsmoker status. Other inclusion criteria included abstinence from any drug for>2 weeks prior to study entry and no beverages (coffee, alcohol or tea et al) intake for >2 weeks before study entry; 4. Willingness to follow the protocol requirement as evidenced by written, informed consent.
Exclusion criteria
Exclusion criteria: 1. Volunteers who cannot meet the inclusion criteria; 2. Had known or suspected hypersensitive to the study drug; 3. The history of using drug which can damage main organs in the past 3 months; 4. Allergic, hypersensitive or with idiosyncratic reaction to nateglinide or any excipient in the study and reference drug or any drug; 5. With any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other systems; 6. Investigator think the subject too poor in compliance to complete the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC(0-infinite);Cmax;AUC(0-t); | — |
Countries
China
Contacts
Public ContactDawei XIAO
Nanjing First Hospital of Nanjing Medical University
Outcome results
None listed