Clinical Trials Logo
  1. Home
  2. Therapeutic Equivalency
  3. NCT05225974

A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects

Therapeutic Equivalency Clinical Trial

Official title:
A Phase 1 Study of Liraglutide Injection and Victoza® in Healthy Chinese Subjects: An Open, Randomized, Single-Dose and Crossover Study

Clinical Trial Summary

The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.

Clinical Trial Description

The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Volunteers were randomized 1:1 at the beginning to receive a single 0.6 mg dose of Victoza® or Liraglutide injection by subcutaneous injection during the first period. Following 7 days washout period, all subjects received the alternate formulation during the second period. Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05225974
Study type Interventional
Source The Affiliated Hospital of Qingdao University
Contact
Status Completed
Phase Phase 1
Start date July 16, 2021
Completion date August 19, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT04467346 - Bioequivalence Study Between Temozolomide Oral Suspension (Ped-TMZ) and Temodal® Capsules Phase 1
Completed NCT00807118 - Phase 1, Single Dose, Crossover Study to Determine Bioequivalence and to Investigate Food Effect Phase 1
Withdrawn NCT01405170 - A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions Phase 1
Completed NCT04885660 - Bioequivalence Evaluation of Two Fixed-dose Combination of Lisinopril 10mg/Levamlodipine Besylate 5mg in Healthy Chinese Subjects Phase 1
Completed NCT05786339 - Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects Phase 1
Completed NCT00709189 - Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women. Phase 1
Completed NCT00658541 - Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets Phase 1
Completed NCT00685165 - Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets Phase 1
Completed NCT00997789 - Bioequivalence of Rebamipide in Korean N/A
Completed NCT00684762 - Fasted Bioavailability Study of Cilostazol Tablets, 100 mg Phase 1
Recruiting NCT04814589 - Bioequivalence of Ezetimibe Tablets in Healthy Subjects Phase 1
Completed NCT03631316 - Pharmacokinetic Parameters of Innovative Valganciclovir Versus Generic Valganciclovir N/A
Recruiting NCT04438720 - Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects Phase 1
Completed NCT01359163 - A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects Phase 1
Completed NCT00650221 - Fasting Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Subjects Phase 1
Completed NCT00648544 - Fed, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Subjects Phase 1
Withdrawn NCT01405131 - A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Phase 1
Withdrawn NCT01405157 - A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions Phase 1
Completed NCT05282940 - Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product Phase 1
Completed NCT06050343 - Comparative Study of Rinsulin R (GEROPHARM) and Humulin Regular (Eli Lilly) Euglycemic Hyperinsulinemic Clamp Method N/A