NCT01938508

Minocycline Bioequivalence Study

Bioequivalence Study Between Two Medications for the Oral Administration of 100 mg of Minocycline in Oral Solids in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study compared the bioavailability of two formulations 100 mg (one capsule or other respectively) of each one of the products, of Minocycline, under fasting conditions, in healthy Mexican volunteers of both sexes. The single dose study under fasting (10 hours prior to study) conditions, cross, with two treatments, two periods, two sequences (2x2) randomized sequence, balanced, and with a washout period of at least 7 days between each dose, in 24 healthy volunteers.

Conditions

• Skin Diseases

Interventions

Type	Name	Description
DRUG	Minocycline	minocycline hydrochloride capsules in microgranules equivalent to 100 mg of minocycline

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-09-10
• Last updated: 2013-11-18

Locations

1 site across 1 country: Mexico