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CKD-841 Pharmacokinetic/Pharmacodynamic Study

NCT03233932 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-07-31

No results posted yet for this study

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.

Conditions

  • Postmenopausal Disorder

Interventions

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.

Sponsors & Collaborators

  • Severance Hospital

    collaborator OTHER

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Min Soo Park, Ph.D · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03233932 on ClinicalTrials.gov