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Mass Balance of Retagliptin to healthy subjects in a single-dose Phase I study

Mass Balance of Retagliptin to healthy subjects in a single-dose Phase I study

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-15006905
Enrollment
Unknown
Registered
2015-07-14
Start date
2015-08-03
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

Test Group:100mg Retagliptin single dose

Sponsors

Beijing Shijitan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. aged 18 to 45 years old, including 18 and 45 years old, healthy male subjects. Into the group of participants age difference is not more than 10 years old; 2. at least 50 kg body weight, body mass index of 19 or and 25 kg/m2 or less; 3. test before medical history, physical examination, laboratory projects all inspection, testing and test related to normal or mildly abnormal without clinical significance, clinical doctors judge considered eligible; 4. have a book signing of the informed consent of the subjects face to face.

Exclusion criteria

Exclusion criteria: 1. has a history of severe system disease, or family history (including the cardiovascular system, digestive system, urinary system, etc.); 2. in drug delivery within 48 hours before taking a special diet or strenuous exercise, or other affect drug absorption, distribution, metabolism and excretion; 3. IV Craig column of phosphoric acid or other statins DPP inhibitors has a history of allergy or intolerance; 4. has a history of allergies to other drugs, or biological agents; 5. in drug delivery within four weeks prior too surgery; 6. in drug delivery within 4 weeks before any live vaccine inoculation; 7. has a history of drug abuse in drug delivery before five years; 8. in drug delivery within four weeks before using any prescription drugs, or into groups within 1 week before the use of prescription drugs or medicine; 9. during 6 months prior to dosing or test often drinkers, that drinking more than 14 units of alcohol a week (1 = 45 mL 360 mL beer or alcohol content of 40% spirits or 150 mL wine); 10. in 3 months before the dosing daily smoking more than 5 pieces, or used any tobacco products during the test; 11. as the subjects participated in nearly a year 3 times or more than 3 times drug clinical subjects; 3 months prior to the test as the subjects to participate any drug clinical trials, or 3 months once blood donors, blood donors, or plan to three months before the test had a transfusion in 4 weeks; 12. did not take effective contraceptive measures or half a year in family planning of the subjects; 13. researchers say adherence is poor, or has any unfavorable factors to participate in the test subjects; 14) the researchers and their family members.

Design outcomes

Primary

MeasureTime frame
Pulse;Respiration;Blood Pressure;Temperature;ECG;X-Ray;

Countries

China

Contacts

Public ContactXinghe Wang
wangxinghe@yahoo.com+86-10-63926401

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026