NCT03233932

CKD-841 Pharmacokinetic/Pharmacodynamic Study

Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 After Subcutaneous Injection in Postmenopausal Female

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A randomized, open-label, single dose, parallel design phase I clinical trial to investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after subcutaneous injection in postmenopausal female.

Detailed description

To investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplinⓡ Inj. 3.75mg after subcutaneous injection in postmenopausal female is the purpose of this trial.

Conditions

• Postmenopausal Disorder

Interventions

Type	Name	Description
DRUG	LeuplinⓡInj	Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
DRUG	CKD-841	Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2017-07-31
• Last updated: 2017-07-31

Locations

1 site across 1 country: South Korea