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Pharmacokinetic Drug Interaction Between Pregabalin and Thioctic Acid.

NCT01808300 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2013-08-22

No results posted yet for this study

Summary

A randomized, open-label, six-sequence, three-period, three-treatment, multiple dosing clinical trial to investigate the pharmacokinetic drug interaction between Pregabalin and Thioctic acid after oral administration in healthy male volunteers.

Conditions

  • Healthy

Interventions

DRUG

Pregabalin 300mg, Thioctic acid 600mg

* A: Pregabalin - Pregabalin 300mg will be administered orally twice a day for 3 days * B: Thioctic acid - Thioctic acid 600mg will be administered orally once a day for 3 days * C: Pregabalin plus Thioctic acid - Pregabalin plus Thioctic acid same way as A and B

Sponsors & Collaborators

  • Unimed Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-07-31
Completion
2013-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01808300 on ClinicalTrials.gov