NCT04840745

The Safety and Pharmacokinetic/Pharmacodynamic Study of CKD-841 in Postmenopausal Female, Phase 1

A Randomized, Single-blinded, Parallel Design Phase I Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. After Subcutaneous Injection in Postmenopausal Female

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

A randomized, single-blinded, parallel design phase I clinical trial to investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. after subcutaneous injection in postmenopausal female

Detailed description

To investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. 3.75 mg after subcutaneous injection in postmenopausal female

Conditions

• Early Puberty

Interventions

Type	Name	Description
DRUG	CKD-841 A-1 3.75mg	Single injection, subcutaneous injection
DRUG	CKD-841 A-1 1.88mg	Single injection, subcutaneous injection
DRUG	CKD-841 D 2.92mg	Single injection, subcutaneous injection
DRUG	Leuplin Inj. 3.75 mg	Single injection, subcutaneous injection

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-10-01
• Completion: 2021-11-01
• First posted: 2021-04-12
• Last updated: 2021-04-19

Locations

1 site across 1 country: South Korea