NCT03233932 is a Phase 1 clinical trial of LeuplinⓡInj in Postmenopausal Disorder, sponsored by Chong Kun Dang Pharmaceutical.

Who is sponsoring NCT03233932?

NCT03233932 is sponsored by Chong Kun Dang Pharmaceutical.

What drugs are being tested in NCT03233932?

Interventions in NCT03233932: LeuplinⓡInj, CKD-841.

What condition does NCT03233932 study?

NCT03233932 studies Postmenopausal Disorder.

Is NCT03233932 still recruiting?

NCT03233932 is currently completed. Last updated 26 July 2017.

Last reviewed 2017-07-26 · How we verify

NCT03233932

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 26 July 2017

What this trial tests

Phase 1 trial testing LeuplinⓡInj in Postmenopausal Disorder in 13 participants. Completed in 1 July 2017.

Timeline

1 April 2016

Primary endpoint
1 July 2017

1 July 2017

Quick facts

Lead sponsor	Chong Kun Dang Pharmaceutical
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	1 April 2016
Primary completion	1 July 2017
Estimated completion	1 July 2017
Sites	1 location across South Korea

Drugs / interventions tested

LeuplinⓡInj — full drug profile →
CKD-841 — full drug profile →

Conditions studied

Postmenopausal Disorder — all drugs for Postmenopausal Disorder →

Sponsor

Chong Kun Dang Pharmaceutical — full company profile →

Who can join

Adults 40 to 65, female only, with Postmenopausal Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Peak Plasma Concentration (Cmax) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
Peak Plasma Concentration (Cmax) in ng/mL
Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
Area Under the plasma drug Concentration-time curve to last measurement (AUClast ) in ng•hr/mL
Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
Area Under the plasma drug Concentration-time curve extrapolated to infinity (AUCinf) in ng•hr/mL
Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
Area Under the plasma drug Concentration-time curve from 7 day to last measurement (AUC7-t) in ng•hr/mL
The time -to-maximal serum or plasma concentrations (Tmax) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
The time -to-maximal serum or plasma concentrations (Tmax) in hr
Terminal half-life (t1/2) Luteinizing Hormone(LH) of Leuprorelin
Time frame: From before injection to up to 1008 hours post injection
Terminal half-life (t1/2) Luteinizing Hormone(LH) in IU/L

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Chong Kun Dang Pharmaceutical trials

Trials by the same sponsor.

NCT07404735 — A Clinical Trial to Compare and Evaluate Evaluate the Pharmacokinetics and Safety of CKD-846 · Phase 1 · not yet recruiting
NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E · Phase 1 · recruiting
NCT07258745 — Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-appro · Phase 1 · recruiting
NCT07304726 — Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.25/12.5/1000mg in Healthy Volunteers · Phase 1 · completed
NCT07304700 — Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.5/10/1000mg in Healthy Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03233932 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Chong Kun Dang Pharmaceutical
Last refreshed: 26 July 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03233932.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing