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Completed

NCT Number: NCT01573663

A Drug-Drug Interaction Study of Ambroxol and Levodropropizine

The purpose of this study is to evaluate the drug-durg interaction between ambroxol and levodropropizine.

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung medical center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male
  • Age between 20 and 55
  • Signed informed consent

Exclusion criteria

  • Has a history of hypersensitivity to IP ingredients
  • Hypotension or hypertension
  • Has a history of acute infection within 14 days of screening

Treatment and study plan

Ambroxol and Levodropropizine

Drug

Ambroxol HCl 30mg & Levodropropizine 60mg, PO, Single dose

Ambroxol

Drug

Ambroxol HCl 30mg, PO, single dose

Levodropropizine

Drug

Levodropropizine 60mg, PO, single dose

Primary outcomes

  1. AUClast

    Time frame: 0-48hrs

  2. Cmax

    Time frame: 0-48hrs

Secondary outcomes

  1. Tmax

    Time frame: 0-48hrs

  2. T1/2

    Time frame: 0-48hrs

  3. AUCinf

    Time frame: 0-48hrs

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

Open Label, Randomized, 3-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Ambroxol HCl and Levodropropizine in Healthy Male Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 9, 2012
Registry last updated
Jul 19, 2012

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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