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
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

ClinicalTrials.gov processed this record on April 17, 2014