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

NCT ID: NCT04877106

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-07
• Study Completion Date: 2018-07-31

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

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 assess the bioequivalence of Sitagliptin Phosphate/metformin Hydrochloride Tablets in healthy Chinese subjects and estimate the pharmacokinetics profiles of Sitagliptin Phosphate/metformin Hydrochloride Tablets. An open-label, randomized, single-dose, two-period, crossover study was conducted in 48 healthy Chinese volunteers under fasted or fed conditions (24 subjects for each condition) to assess the bioequivalence between two formulations of Sitagliptin Phosphate/metformin Hydrochloride Tablets. Blood samples were collected at specified time intervals, and the plasma concentrations of sitagliptin and metformin were determined by a validated liquid chromatography mass spectrum/ mass spectrum method. Pharmacokinetic and bioavailability parameters were estimated via non-compartmental methods. Adverse events were also recorded. If the 90% confidence intervals of the ratios of geometrical mean of test and reference formulations for Cmax, AUC0-t and AUC0-∞ are all within the predefined bioequivalence criteria range of 80%-125% for sitagliptin and metformin, the two formulations can be considered bioequivalent.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sitagliptin Phosphate/metformin Hydrochloride Tablets (JANUMET®)

JANUMET®, 50mg/850mg, batch no. M047893, manufactured by MSD Pharma (Singapore) Pte.Ltd

Group Type: ACTIVE_COMPARATOR

Sitagliptin Phosphate/metformin Hydrochloride Tablets(JANUMET®,50mg/850mg)

Intervention Type: DRUG

The subjects randomly received single oral administration of Sitagliptin Phosphate/metformin Hydrochloride Tablets (JANUMET®, 50mg/850mg)

Sitagliptin Phosphate/metformin Hydrochloride Tablets

50mg/850mg, batch no. 161006, manufactured by Tonghua Dongbao Pharmaceutical Co., Ltd.

Group Type: EXPERIMENTAL

Sitagliptin Phosphate/metformin Hydrochloride Tablets (50mg/850mg)

Intervention Type: DRUG

The subjects randomly received single oral administration of Sitagliptin Phosphate/metformin Hydrochloride Tablets (50mg/850mg)

Interventions

Sitagliptin Phosphate/metformin Hydrochloride Tablets(JANUMET®,50mg/850mg)

The subjects randomly received single oral administration of Sitagliptin Phosphate/metformin Hydrochloride Tablets (JANUMET®, 50mg/850mg)

Intervention Type: DRUG

Sitagliptin Phosphate/metformin Hydrochloride Tablets (50mg/850mg)

The subjects randomly received single oral administration of Sitagliptin Phosphate/metformin Hydrochloride Tablets (50mg/850mg)

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu Doctor Cao

Role: PRINCIPAL_INVESTIGATOR

the study director of phase I clinical research center

Locations

Phase I Clinical Research Center

Qingdao, Shanndong, China

Countries

China

Other Identifiers

DBH061L012017

Identifier Type: -

Identifier Source: org_study_id