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OpenTrials
Completed

NCT Number: NCT03864432

An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)

To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of Gemigliptin and Food effect in healthy Chinese subjects.

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Key information

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central hospital

Shanghai, 200002, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female subjects (aged 19~45 years at the time of screening)
  • Subjects weighing between 50kg (inclusive) and 90kg (exclusive), and having a body mass index (BMI) of 17.1~25.8 (inclusive of limits).
  • Subjects with a fasting plasma glucose (FPG) of 70~110mg/dL (inclusive of limits) at the time of screening
  • Subjects who are willing to participate in the entire study cycle and comply with the study protocol (including contraception). Subjects who can sign the written Informed Consent Form after being informed of the study procedures.

Exclusion criteria

  • Those with a history of allergies including drug allergies (aspirin, antibiotics, etc.), or other clinically significant allergies.
  • Those with diseases of the liver (including carriers of hepatitis virus), kidney, respiratory system, endocrine system, nervous system or immune system. Those with a medical history of hematology/oncology, psychiatry or cardiovascular diseases.
  • Those with a medical history of gastrointestinal diseases (ulcers, Crohn's disease, etc.) or surgery (excluding simple appendectomy or hernia repair), and these situations can affect the absorption of the study drug.

Treatment and study plan

Gemigliptin 25mg

Drug

Gemigliptin 50mg 1/2T

Gemigliptin 50mg

Drug

Gemigliptin 50mg 1T

Gemigliptin 100mg

Drug

Gemigliptin 50mg 2T

Gemiglptin 50mg multiple dose

Drug

Gemigliptin 50mg 1T * 10days

Primary outcomes

  1. AUClast of Gemigliptin

    Time frame: 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h

  2. Cmax of Gemigliptin

    Time frame: 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 6, 2019
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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