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CompletedNCT04087525Updated Sep 12, 2019

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

A Phase 1 interventional study of HIP1701 and HGP1809 in Health, Subjective, sponsored by Hanmi Pharmaceutical Company Limited. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-12.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2018, registered Sep 2019).
Phase
Phase 1
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Health, Subjective
03

In context

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Sequence 1

    Period 1 : Fasted state + HIP1701, Period 2 : Fasted state + HGP1809

    Drug: HIP1701 · Drug: HGP1809

  • Experimental
    Sequence 2

    Period 1 : Fasted state + HGP1809, Period 2 : Fasted state + HIP1701

    Drug: HIP1701 · Drug: HGP1809

Interventions

  • DrugHIP1701

    Vildagliptin

  • DrugHGP1809

    Vildagliptin

06

What researchers measure

Primary outcomes

  1. Cmax of Vildagliptin

    pharmacokinetic evaluation

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

  2. AUClast of Vildagliptin

    pharmacokinetic evaluation

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

Secondary outcomes

  1. AUCinf of Vildagliptin

    pharmacokinetic evaluation

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

  2. Tmax of Vildagliptin

    pharmacokinetic evaluation

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

  3. t1/2 of Vildagliptin

    pharmacokinetic evaluation

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

  4. CL/F of Vildagliptin

    pharmacokinetic evaluation

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

  5. Vd/F of Vildagliptin

    pharmacokinetic evaluation

    Time frame: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour

07

Study locations

1 site
  • Yonsei University Health System, Severance Hospital
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04087525
Lead sponsor
Hanmi Pharmaceutical Company Limited
Responsible party
Sponsor
First posted
Sep 12, 2019
Start date
Oct 23, 2018
Primary completion
Nov 27, 2018
Completion
Nov 27, 2018
Last update
Sep 12, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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