Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects

Drug Drug Interaction Clinical Trial

Official title:

A Randomized, Open-label, Three-sequence, Three-period, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacodynamics of DWC202202 in Combination With DWP14012 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05574374
• Other study ID #: DW_DWP14012110
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2022
• Est. completion date: March 6, 2023

Study information

• Verified date: April 2023
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, open-label, three-sequence, three-period, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacodynamics of DWC202202 in combination with DWP14012 in healthy subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 6, 2023
• Est. primary completion date: March 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy adults aged = 19 and = 50 years at screening

• Subjects with a body weight = 50.0 kg to = 90.0 kg with a body mass index (BMI) of = 18.0 kg/m2 to = 27.0 kg/m2 at screening

? BMI (kg/m2) = body weight (kg)/[height (m)]2

• Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information

• Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.

Exclusion Criteria:

• Subjects with a history related to blood clotting disorder or bleeding

• Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, antibiotics, etc.

• Subjects with a history of drug abuse or a positive result of using abusive drugs in the urine drug screen

• Subjects who participated in other clinical trials (including bioequivalence studies) within 6 months prior to the first scheduled dose of the IP

• Subjects who donated whole blood within 2 months, donated blood components within 1 month, or received blood transfusion within 1 month prior to the first scheduled dose

• Subjects who are unable to refrain from grapefruit-containing products from 3 days prior to the first scheduled dose until last discharge from hospital

• Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.

• Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration

• Subjects who are smoking

Related Conditions & MeSH terms

• Drug Drug Interaction

Intervention

Drug:
• DWP14012
Potassium-competitive acid blocker
• DWC202202
Clopidogrel Bisulfate
• DWC202203
Proton pump inhibitor

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University 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	Emax		up to 50 days
Primary	AUEC0-24		up to 50 days
Secondary	DWC202202 Cmax,ss		up to 50 days
Secondary	DWC202202 active metabolite Cmax,ss		up to 50 days
Secondary	DWC202202 AUCtau,ss		up to 50 days
Secondary	DWC202202 active metabolite AUCtau,ss		up to 50 days
Secondary	DWC202202 AUCinf,ss		up to 50 days
Secondary	DWC202202 active metabolite AUCinf,ss		up to 50 days
Secondary	DWC202202 Tmax,ss		up to 50 days
Secondary	DWC202202 active metabolite Tmax,ss		up to 50 days
Secondary	DWC202202 t1/2,ss		up to 50 days
Secondary	DWC202202 active metabolite t1/2,ss		up to 50 days
Secondary	DWC202202 Cmin,ss		up to 50 days
Secondary	DWC202202 active metabolite Cmin,ss		up to 50 days
Secondary	DWC202202 Cavg,ss		up to 50 days
Secondary	DWC202202 active metabolite Cavg,ss		up to 50 days
Secondary	DWC202202 CLss/F		up to 50 days
Secondary	DWC202202 Vd,ss/F		up to 50 days
Secondary	DWC202202 PTF (peak to trough fluctuation)		up to 50 days
Secondary	DWC202202 active metabolite PTF (peak to trough fluctuation)		up to 50 days
Secondary	DWC202202 R		up to 50 days
Secondary	DWC202202 active metabolite MR		up to 50 days