NCT01808300

Pharmacokinetic Drug Interaction Between Pregabalin and Thioctic Acid.

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Unimed Pharmaceuticals · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-07-01
• Completion: 2013-08-01
• First posted: 2013-03-11
• Last updated: 2013-08-22