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Trial record 51 of 425 for:    Pregabalin

A Open-label, Randomized, Crossover Study to Assess PK of Pregabalin

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ClinicalTrials.gov Identifier: NCT02783183
Recruitment Status : Completed
First Posted : May 26, 2016
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation

Brief Summary:
The purpose of this trial to compare the pharmacokinetic characteristics of YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and AUCtau and secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.

Condition or disease Intervention/treatment Phase
Peripheral Nueropathy Pain Drug: YHD1119 Drug: Lyrica Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Open-label, Radomized, Crossover Clinical Trial to Assess the Pharmacokinetics of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR in Healthy Male Volunteers
Study Start Date : June 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: YHD1119
Pregabalin 300mg
Drug: YHD1119
2 by 2
Other Name: Pregabalin 300mg

Drug: Lyrica
2 by 2
Other Name: Pregabalin 150mg

Active Comparator: Lyrica
Pregabalin 150mg
Drug: YHD1119
2 by 2
Other Name: Pregabalin 300mg

Drug: Lyrica
2 by 2
Other Name: Pregabalin 150mg




Primary Outcome Measures :
  1. Cmax,ss [ Time Frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours ]
  2. AUCtau [ Time Frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours ]

Secondary Outcome Measures :
  1. AUClast,ss [ Time Frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours ]
  2. AUCinf,ss [ Time Frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours ]
  3. Tmax,ss [ Time Frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours ]


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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 19~50 years old, healthy male volunteers
  • >55Kg(Body weight) and 18.5<BMI<28

Exclusion Criteria:

  • AST or ALT > 3 * Upper normal range (Lab)
  • Total bilirubin > 2.0 mg/dl
  • Systolic BP >140 OR <90, Diastolic BP >100 OR <60

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Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT02783183     History of Changes
Other Study ID Numbers: YHD1119-103
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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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
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs