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Randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01420913
First Posted: August 22, 2011
Last Update Posted: August 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yuhan Corporation
  Purpose

The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A, YHD1119 B, YHD1119 C and Lyrica capsule.

YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation.

Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T max,ss, t 1/2


Condition Intervention Phase
Healthy Drug: Pregabalin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Randomized,Open-label,Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Cmax,ss [ Time Frame: 36 hr ]
  • AUCtau [ Time Frame: 36 hr ]
  • Safety monitoring [ Time Frame: 14 days ]
    Laboratory findings Adverse event


Secondary Outcome Measures:
  • AUClast AUCinfinity Tmax,ss t1/2 [ Time Frame: 36 hour ]
  • AUCinfinity [ Time Frame: 36 hr ]
  • Tmax,ss [ Time Frame: 36 hr ]
  • t 1/2 [ Time Frame: 36 hr ]

Enrollment: 28
Study Start Date: August 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lyrica capsule(Pregabalin 150mg) Drug: Pregabalin
Pregabalin 300mg a day
Experimental: YHD1119 A(Pregabalin SR 300mg) Drug: Pregabalin
Pregabalin 300mg a day
Experimental: YHD1119 B(Pregabalin SR 300mg) Drug: Pregabalin
Pregabalin 300mg a day
Experimental: YHD1119 C(Pregabalin SR 300mg) Drug: Pregabalin
Pregabalin 300mg a day

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20~45 years old, healthy adult male subject
  • >55 Kg(Body weight) and < ideal body weight ± 20%

Exclusion Criteria:

  • AST or ALT > 1.25 * Upper normal range (Lab)
  • Total bilirubin > 1.5 * Upper normal range
  • Systolic BP >140 OR <100, Diastolic BP >90 OR <65
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420913


Locations
Korea, Republic of
Seoul ST.Mary Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
  More Information

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01420913     History of Changes
Other Study ID Numbers: YCD207
First Submitted: August 17, 2011
First Posted: August 22, 2011
Last Update Posted: August 22, 2011
Last Verified: August 2011

Keywords provided by Yuhan Corporation:
To evaluate the pharmacokinetic characteristics of Lyrica, YHD1119 A,B,C

Additional relevant MeSH terms:
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs