A Pharmacokinetic Study of DW6012 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers

NCT05403281 | Completed Phase 1

• 1 other identifier: DW6012-I-1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of DW6012 and each component in healthy adult volunteers.

Conditions

Healthy Subjects

Keywords

Dapagliflozin; Sitagliptin; sitagliptin phosphate; Dapagliflozin propanediol

Outcome Measures

Primary Outcomes (2)

• AUC0-t of Dapagliflozin and Sitagliptin

  up to 48 hours

• Cmax of Dapagliflozin and Sitagliptin

  up to 48 hours

Secondary Outcomes (6)

• AUCinf

  up to 48 hours

• Tmax

  up to 48 hours

• t1/2

  up to 48 hours

• CL/F

  up to 48 hours

• Vd/F

  up to 48 hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1: Dapagliflozin and Sitagliptin / Period 2: DW6012

Drug: DW6012

Sequence B

EXPERIMENTAL

Period 1: DW6012/ Period 2: Dapagliflozin and Sitagliptin

Drug: DW6012

Interventions

DW6012 DRUG

Drug: DW6012 Single oral administration of DW6012 after an overnight fast Drug: Dapagliflozin and Sitagliptin Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast

Also known as: Dapagliflozin and Sitagliptin

Sequence A; Sequence B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects aged up to 19 years
• Subjects weighing at least 50.0 kg and no more than 100 kg (inclusive) with a BMI between 18.5 kg/m2 and 30.0 kg/m2
• Subjects with neither congenital nor chronic diseases requiring treatment, and no abnormal symptoms or findings upon medical examination
• Subjects considered eligible for the study participation in accordance to the results of clinical laboratory tests, vital signs, physical examinations and 12-lead ECG conducted at the time of screening, based on the investigational product (IP) characteristics
• Subjects who has a full understanding in participation of the study, voluntarily provide a written consent in participation, and give full agreement in following the subject guidelines throughout the entire study period

You may not qualify if:

• Subjects with any clinically significant hepatic, renal, nervous, respiratory, endocrine, circulatory, tumor, genitourinary, cardiovascular, digestive, musculoskeletal systemic diseases or other medical history
• Subjects with genetic problems such as Lapp lactase deficiency (Lapp) or galactose intolerant galactose due to galactose intolerance
• Subjects with a past medical history of gastrointestinal disease or gastrointestinal surgeries which may affect the absorption, distribution, metabolism and excretion of the IP
• Pregnant subjects with a positive urine HCG test, or lactating female subjects
• Subjects with hypersensitivity reactions or a clinically significant medical history of hypersensitivity reactions to drug substances and additives containing drug substances or other drugs
• Subjects with clinically significant 12-lead ECG findings at the time of screening
• Subjects with clinically significant laboratory test results as follows: Liver function test (AST, ALT, ALP, γ-GTP and total bilirubin), Creatinine, eGFR
• Subjects with a past history of drug abuse or a positive urine drug test
• Subjects with SBP ≥ 150 mmHg or ≤ 90 mmHg; DBP ≥ 100 mmHg or ≤ 60 mmHg; PR ≤ 40 bpm or ≥ 100 bpm at the time of screening
• Subjects following an unusual diet or consumption of food which may affect the absorption, distribution, metabolism and excretion of the IP
• Subjects who have administered any prescription drugs or herbal medicines that may affect the characteristics of clinical investigational drugs within 2 weeks prior to the first administration date, or have administered any over-the-counter (OTC) or vitamin preparations within 10 days
• Subjects taking drugs known to significantly induce or inhibit drug metabolizing enzymes, including barbitals within 1 months prior to the first IP administration
• Subjects who have participated and were given any other study drugs in other clinical study within 6 months prior to the first IP administration
• Subjects who have consistently drunk alcohol within 6 months
• Subjects who have smoked more than 10 cigarettes/day on average

Sponsors & Collaborators

• Dong Wha Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

MeSH Terms

Interventions

dapagliflozin; Sitagliptin Phosphate

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: June 3, 2022
• Study Start: November 5, 2021
• Primary Completion: December 3, 2021
• Study Completion: March 28, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)