Pharmacokinetics and Safety Study of Rifamycin SV-MMX® 600 mg Tablets After Single and Multiple t.i.d. Doses in Healthy Male and Female Volunteers. Single and Multiple Dose, Open Label, Pharmacokinetics and Safety Study

NCT02969252 Phase 1 COMPLETED

The objective of the study was to evaluate the pharmacokinetics and the safety of rifamycin SV after single and multiple doses of Rifamycin SV-MMX® 600 mg tablets administered to male and female healthy subjects.

Details

Lead sponsor	Cosmo Technologies Ltd
Phase	Phase 1
Status	COMPLETED
Enrolment	18
Start date	2015-07

Conditions

• Healthy

Interventions

• Rifamycin SV-MMX® 600

Primary outcomes

• Cmax — Day 1
  Cmax,0-24 h
• Cmax — Day 1
  Cmax,0-6
• tmax — Day 1
  tmax,0-24
• tmax — Day 1
  tmax,0-6
• AUC — Day 1
  AUC 0-24
• AUC — Day 1
  AUC 0-6