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:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01420913
First received: August 17, 2011
Last updated: August 19, 2011
Last verified: August 2011
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • AUCtau [ Time Frame: 36 hr ] [ Designated as safety issue: No ]
  • Safety monitoring [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Laboratory findings Adverse event


Secondary Outcome Measures:
  • AUClast AUCinfinity Tmax,ss t1/2 [ Time Frame: 36 hour ] [ Designated as safety issue: Yes ]
  • AUCinfinity [ Time Frame: 36 hr ] [ Designated as safety issue: No ]
  • Tmax,ss [ Time Frame: 36 hr ] [ Designated as safety issue: No ]
  • t 1/2 [ Time Frame: 36 hr ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420913

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

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01420913     History of Changes
Other Study ID Numbers: YCD207
Study First Received: August 17, 2011
Last Updated: August 19, 2011
Health Authority: Korea: Food and Drug Administration

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014