Status:
COMPLETED
Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
An open-label, randomized, single-dose, two-period, two-group, crossover study was conducted in 48 healthy Chinese volunteers under fasted or fed conditions (24 volunteers for each condition) to asses...
Detailed Description
The single-dose randomized, open-label, two-period crossover study was executed in the Phase I Clinical Research Center of the Affiliated Hospital of Qingdao University. This study was conducted to as...
Eligibility Criteria
Inclusion
- Healthy male or female aged between 18 and 45 years old (including the critical value).
- The body mass index is in the range of 19-28 kg/m2 (including the critical value). The weight of male is not less than 50 kg, and that of female is not less than 45 kg (including the critical value).
- Subjects who had not any medical history of cardiovascular, digestive, respiratory, nervous or hepatic/renal impairment. The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: physical examination, 12-lead ECG, vital sign measurements, and laboratory safety tests.
- The subjects have no family planning within 6 months and could select contraceptive method.
- Before the study, all subjects have been informed of the study's purpose, protocol, benefits, and risks, and signed the informed consent voluntarily.
- The subjects could complete the study according to the protocol.
Exclusion
- Being allergy to the study medications, smoking, alcohol abuse.
- Participation in another clinical trial within 3 months.
- Any history of hypersensitivity, needlesickness or idiosyncratic reactions to any food or drug;
- Any use of other prescription drugs (including contraceptive) 14 days prior to medication for this study;
- Any use of prescription or over-the-counter drugs, functional vitamin, herbal/ alcohol products, grapefruit-containing or caffeine/xanthine-rich food and beverages 48 h prior to medication for this study; dysphagia or having special dietary requirements;
- occurring acute disease in the screening period or before the medication lactating or pregnant women;
Key Trial Info
Start Date :
April 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04877106
Start Date
April 7 2018
End Date
July 31 2018
Last Update
May 7 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Phase I Clinical Research Center
Qingdao, Shanndong, China, 266003