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Completed

NCT Number: NCT01651481

Study to Evaluate the Pharmacokinetics and Safety of Singulair and Xyzal in Free Combination and Fixed-dose Combination

The purpose of this study is to evaluate the pharmacokinetics and safety of Singulair (10 mg) and Xyzal (5 mg) in free combination and fixed-dose combination as HCP1102

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Key information

Conditions

Rhinitis Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections

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

HCP1102

Drug

Other names: Singulair and Xyzal combination tablet

Singulair and Xyzal

Drug

Other names: coadministration of Singulair and Xyzal

Primary outcomes

  1. AUClast

    Time frame: 0-34hr

  2. Cmax

    Time frame: 0-34hr

Secondary outcomes

  1. tmax

    Time frame: 0-34hr

  2. AUCinf

    Time frame: 0-34hr

  3. t1/2

    Time frame: 0-34hr

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

Open-label, Randomized, Single Dose Crossover Study to Evaluate the Pharmacokinetics and Safety of Singulair (10 mg) and Xyzal (5 mg) in Free Combination and Fixed-dose Combination as HCP1102 in Healthy Male Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 27, 2012
Registry last updated
Aug 13, 2013

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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