Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05321732
Other study ID # DW_DWP306001101
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received
Last updated
Start date December 10, 2021
Est. completion date August 2022

Study information

Verified date January 2022
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety of co-administration of DWP16001 2 mg and DWC202010 (DWC202010 37.5 mg) in healthy adults compared to the case of administration alone.


Description:

The study design is a randomized, open-label, multiple-dose, crossover clinical trial. The patients were randomly assigned to each group. Primary endpoint was Cmax,ss and AUCtau,ss of DWP16001 and DWC202010. Secondary endpoints were Cmax,ss, Tmax,ss, t1/2, CLss/F, fluctuation of DWP16001 and DWC202010, and Cmax,ss, Cmin,ss, AUCtau,ss, Tmax,ss, and metabolic ratio of DWP16001 metabolites(M1).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 24
Est. completion date August 2022
Est. primary completion date August 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility Inclusion Criteria: - Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DWP16001
DWP16001 A mg
DWP202010
DWP202010 B mg

Locations

Country Name City State
Korea, Republic of Yonsei University Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak Plasma Concentration (Cmax,ss) of DWP16001 Before IP administration of Day 1, Day 5, and Day 6
Primary Area under the plasma concentration versus time curve (AUCtau,ss) of DWP16001 Before IP administration of Day 1, Day 5, and Day 6
Primary Peak Plasma Concentration (Cmax,ss) of DWC202010 Before IP administration and post-dose up to 24 hours
Primary Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010 Before IP administration and post-dose up to 24 hours
See also
  Status Clinical Trial Phase
Completed NCT05001152 - Taste Assessment of Ozanimod Phase 1
Completed NCT05029518 - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability Phase 1
Completed NCT04493255 - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants Phase 1
Completed NCT03457649 - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers Phase 1
Completed NCT00995891 - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed NCT05043766 - Evaluation of Oral PF614 Relative to OxyContin Phase 1
Completed NCT05050318 - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively Phase 4
Completed NCT04466748 - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects Phase 1
Completed NCT00746733 - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Phase 1
Recruiting NCT05929651 - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy Phase 4
Completed NCT05954039 - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect N/A
Completed NCT05045716 - A Study of Subcutaneous Lecanemab in Healthy Participants Phase 1
Active, not recruiting NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children Phase 3
Completed NCT05533801 - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Phase 1
Not yet recruiting NCT03931369 - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Phase 2
Completed NCT03279146 - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects Phase 1
Completed NCT06027437 - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants Phase 1
Recruiting NCT05619874 - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity N/A
Completed NCT05553418 - Investigational On-body Injector Clinical Study N/A
Completed NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers Phase 1