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

NCT04877106 | Completed Phase 1 DMC

• 1 other identifier: DBH061L012017
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• The ratios of geometrical mean

  The two preparations were considered bioequivalent if the 90% CIs of the ratios of the primary pharmacokinetics parameters were within the predefined acceptance range of 80%-125%.

  80 days

Secondary Outcomes (1)

• The occurrence rate of adverse events

  80 days

Study Arms (2)

Sitagliptin Phosphate/metformin Hydrochloride Tablets (JANUMET®)

ACTIVE COMPARATOR

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

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

Sitagliptin Phosphate/metformin Hydrochloride Tablets

EXPERIMENTAL

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

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

Interventions

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

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

Sitagliptin Phosphate/metformin Hydrochloride Tablets (JANUMET®)

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

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

Sitagliptin Phosphate/metformin Hydrochloride Tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Phase I Clinical Research Center

Qingdao, Shanndong, 266003, China

Location

MeSH Terms

Interventions

Sitagliptin Phosphate; Metformin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Yu Doctor Cao

  the study director of phase I clinical research center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 7, 2021
• Study Start: April 7, 2018
• Primary Completion: May 20, 2018
• Study Completion: July 31, 2018
• Last Updated: May 7, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)