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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01420913
• Date of registration: 17/08/2011
• Primary sponsor: Yuhan Corporation
• Public title: Randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects
• Scientific title: Randomized,Open-label,Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects
• Date of first enrolment: August 2011
• Target sample size: 28
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01420913
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Pregabalin

Primary Outcome(s)

AUCtau [Time Frame: 36 hr]

Cmax,ss [Time Frame: 36 hr]

Safety monitoring [Time Frame: 14 days]

Secondary Outcome(s)

AUCinfinity [Time Frame: 36 hr]

AUClast AUCinfinity Tmax,ss t1/2 [Time Frame: 36 hour]

t 1/2 [Time Frame: 36 hr]

Tmax,ss [Time Frame: 36 hr]

Secondary ID(s)

YCD207

Source(s) of Monetary Support

Please refer to primary and secondary sponsors