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Time-Action Profile of an Oral Enteric Insulin Formulation in Chinese Healthy Volunteers

Time-Action Profile of an Oral Enteric Insulin Formulation in Chinese Healthy Volunteers

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12001872
Enrollment
Unknown
Registered
2012-01-12
Start date
2010-02-20
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Interventions

1:oral administration of the enteric insulin 50IU
2:oral administration of the enteric insulin 100IU
3:oral administration of the enteric insulin 200IU
4:NPH insulin injection 6IU

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 29 Years

Inclusion criteria

Inclusion criteria: 1. subject is a healthy male or female; 2. Age between 18 and 50; 3. BMI 19 to 24kg/m2; 4. No diseases of haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other systems; No obvious abnormalities of the laboratory values; 5. No family history of diabetes or obesity; 6. Nonsmoker status, abstinence from any drug and no beverages (coffee, alcohol or tea et al) intake during study; 7. Willingness to follow the protocol requirement as evidenced by written, informed consent.

Exclusion criteria

Exclusion criteria: 1. With any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other systems; 2. Allergic reaction to any drug, postural hypotension,blood pressure (systolic140 mmHg; diastolic>90 mmHg) heart rate100 bpm; 10. Positive serum hepatitis B surface antigen or hepatitis C antibody; 11. Positive serum HIV-1 or HIV-2 antibody; 12. Consumption of alcohol during study; 13. body weight greater than 5% 0 to 12 months before study.

Design outcomes

Primary

MeasureTime frame
GIR-AUC(0-t);effective duration;

Countries

China

Contacts

Public ContactYerong Yu
yerongyu@scu.edu.cn+86 18980601304

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 25, 2026