A Study to Evaluate the Pharmacokinetics and Safety of HIP1701 in Healthy Subjects

Health, Subjective Clinical Trial

Official title:

A Randomized, Open-Label, Single-Dose, Two-way Crossover Study to Compare Pharmacokinetic Properties and Safety of HIP1701 and HGP1809 in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087525
• Other study ID #: HM-VILT-101
• Status: Completed
• Phase: Phase 1
• Start date: October 23, 2018
• Est. completion date: November 27, 2018

Study information

• Verified date: September 2019
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HIP1701 in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 27, 2018
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Age 19~55 years in healthy volunteers

2. BMI is more than 18.5 kg/m^2 , no more than 24.9 kg/m^2

3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system

2. Subjects who judged ineligible by the investigator

Related Conditions & MeSH terms

• Health, Subjective

Intervention

Drug:
• HIP1701
Vildagliptin
• HGP1809
Vildagliptin

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Primary	AUClast of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Secondary	AUCinf of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Secondary	Tmax of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Secondary	t1/2 of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Secondary	CL/F of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
Secondary	Vd/F of Vildagliptin	pharmacokinetic evaluation	pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour