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Bioequivalence Study of Tipranavir Stored at Controlled Temperature Compared With Tipranavir Stored at Controlled Refrigerated Conditions, Orally Co-administered With Ritonavir in Healthy Male and Female Volunteers

NCT02253888 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-10-01

No results posted yet for this study

Summary

The objective of this trial was to establish the bioequivalence of Tipranavir (TPV) 250 mg self emulsifying drug delivery system (SEDDS) capsules that had been stored at a controlled temperature of 30°C and controlled relative humidity (RH) of 70% in comparison with TPV 250 mg SEDDS capsules stored at controlled refrigerated conditions between 2°C and 8°C

Conditions

  • Healthy

Interventions

DRUG

TPV - Room condition

DRUG

TPV - Refrigerated conditions

DRUG

Ritonavir (RTV)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2005-06-30

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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 NCT02253888 on ClinicalTrials.gov