Bioequivalence of Sitagliptin Phosphate/Metformin Hydrochloride Tablets in Healthy Chinese Subjects

• Status: Completed
• Trial end date: 2018-07-31
• Target enrollment: 0
• Participant gender: All

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 assess the bioequivalence between two formulations of Sitagliptin Phosphate/metformin Hydrochloride Tablets.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Affiliated Hospital of Qingdao University
• Treatments: Metformin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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;