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OpenTrials
Completed

NCT Number: NCT05991401

Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults

This is an open-label, fixed-sequence, phase 1 study to evaluate the effect of clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults.

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Key information

Conditions

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult volunteer 19 years to 50 years
  • Body weight in the range of 40.0 to 90.0 kg and body mass index in the range of 18 to 28kg/m2
  • In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in a surgical infertility condition (both tubular obstruction, hysterectomy, bilateral tubular resection, etc.)
  • The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
  • The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire

Exclusion criteria

  • Subject with serious active hepatobiliary (severe hepatic failure, etc.), renal(severe renal impairment, etc.), neurologic, immunologic, respiratory, digestive, endocrine, hematologic, cardiovascular(heart failure, Torsades de pointes, etc), urologic, psychological disease, sexual disorder, ophthalmologic or history of such disease
  • Subject with gastrointestinal disease (peptic ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or history of such disease/surgery (excluding simple appendix surgery, hernia surgery, hemorrhoid surgery)
  • Subject Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.)
  • Subject who is positive for serum test results (hepatitis B test, hepatitis C test, HIV test, syphilis test)
  • Subject who have history of drug/alcohol abuse or Positive in Urine drug screen test
  • Subject who determined that Investigator is unfit to participate in a clinical trial due to other reasons other than the above items

Treatment and study plan

DA-8010 5mg

Drug

[Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg

Clarithromycin 500mg

Drug

[Period 2] DA-8010 5mg, Clarithromycin 500mg

Rifampicin 600mg

Drug

[Period 3] DA-8010 5mg, Rifampicin 600mg

Primary outcomes

  1. Peak Plasma Concentration of DA-8010 (Cmax)

    Time frame: 0~48hours

  2. Area under the plasma concentration versus time curve of DA-8010 (AUClast)

    Time frame: 0~48hours

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Fixed-sequence, Phase 1 Clinical Trial to Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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