臨床研究等提出・公開システム

Japanese

Date of registration	July. 14, 2026
Last modified on	July. 14, 2026
Trial ID	jRCT2071260058

Scientific Title	Single-Dose Fasting Bioequivalence Study of Linagliptin Film Coated Tablets (5 mg, Mylan) versus Trazenta Tablets (5 mg, Boehringer Ingelheim) in Healthy Japanese Volunteers (Not applicable)
Public Title	Single-Dose Fasting Bioequivalence Study of Linagliptin Film Coated Tablets (5 mg, Mylan) versus Trazenta Tablets (5 mg, Boehringer Ingelheim) in Healthy Japanese Volunteers (Not applicable)

Contact for Scientific Queries	Name	Kondo N/A Yuko
	Affiliation	Viatris Pharmaceuticals Japan G.K.
	Address	1-3-1, Azabudai, Minato-ku, Tokyo, Japan
	Telephone	+81-3-5656-0400
	E-mail	yuko.kondo@viatris.com
Contact for Public Queries	Name	Kondo N/A Yuko
	Affiliation	Viatris Pharmaceuticals Japan G.K.
	Address	1-3-1, Azabudai, Minato-ku, Tokyo, Japan
	Telephone	+81-3-5656-0400
	E-mail	yuko.kondo@viatris.com

Recruitment status	Complete

Anticipated date of first enrollment		July. 14, 2026
Actual date of first enrollment		Oct. 04, 2025
Target sample size		36
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- healthy volunteer - Adequate venous access in both arms for the collection of a number of blood samples during the study. - Able to understand and sign the written Informed Consent Form. - Willing to follow the protocol requirements and comply with protocol restrictions. All subjects should be judged by the Principal Investigator or Medical Sub-Investigator as normal and healthy, etc.
	Exclusion Criteria	Social Habits: a. Ingestion of any alcoholic beverage within the 48 hours prior to the initial administration of study medication. b. Ingestion of any caffeine- or xanthine-containing food or beverage within the 24 hours prior to the initial administration of study medication. c. Ingestion of any vitamins or herbal products within 7 days prior to the initial administration of the study medication. d. Any recent, significant change in dietary or exercise habits. e. History of drug and/or alcohol abuse within one year of start of study. f. Use of any nicotine containing product during any in-house study period. Medications: a. Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial administration of study medication. b. Use of any depot injection or implant of any drug within 3 months prior to initial administration of study medication. c. Use of any medication, herbal supplement, or vitamin known to induce or inhibit hepatic enzyme activity within 28 days prior to the initial administration of study medication. Any conditions clinically significant judged by the Principal Investigator or Medical Sub-Investigator, etc.
	Age Minimum	18age old over
	Age Maximum	55age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Type 2 diabetes
Intervention(s)		After an overnight fast of at least 10 hours, one of the investigational treatments will be administered to the volunteers on Day 1 of each study period; in accordance with the randomization code.
Health Condition(s) Keyword		Type 2 diabetes
Intervention(s) Keyword		Oral administration
Health Condition(s) Code		D003924
Intervention(s) Code		D052698
Primary Outcome(s)		Evaluate pivotal fasting bioequivalence.
Secondary Outcome(s)		Not applicable

Primary Sponsor	Viatris Pharmaceuticals G.K.

Secondary Sponsor

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	Tenyamachi 6-18, Hakata, Fukuoka-city, Japan, Fukuoka
Telephone	+81-92-283-7701
E-Mail	koki-furusho@lta-med.com
Approval Status	Approval
Date of approval	Aug. 28, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none