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 | Completed Phase 1

• 1 other identifier: 1182.93
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity)

  up to 72 hours after drug administration

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 72 hours after drug administration

Secondary Outcomes (10)

• AUC0-tz (area under concentration-time curve of the analyte in plasma over the time interval of 0 to time of last quantifiable data point)

  up to 72 hours after drug administration

• AUC0-72 (area under concentration-time curve of the analyte in plasma over the time interval t0h to t72h)

  up to 72 hours after drug administration

• tmax (time from dosing to the maximum concentration of the analyte in plasma)

  up to 72 hours after drug administration

• λz (terminal rate constant in plasma)

  up to 72 hours after drug administration

• t1/2 (terminal half-life of the analyte in plasma)

  up to 72 hours after drug administration

Study Arms (2)

TPV/r - Room condition

EXPERIMENTAL

Drug: TPV - Room condition; Drug: Ritonavir (RTV)

TPV/r - Refrigerated conditions

EXPERIMENTAL

Drug: TPV - Refrigerated conditions; Drug: Ritonavir (RTV)

Interventions

TPV - Room condition DRUG

TPV/r - Room condition

TPV - Refrigerated conditions DRUG

TPV/r - Refrigerated conditions

Ritonavir (RTV) DRUG

TPV/r - Refrigerated conditions; TPV/r - Room condition

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females with a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG and clinical laboratory tests that have:
• No findings that are abnormal or of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Acceptable laboratory values that indicate adequate baseline organ function at time of screening. Laboratory values are considered acceptable if the severity is less than or equal to Grade 1, according to the AIDS Clinical Trials Group (ACTG) Division of Acquired Immunodeficiency Syndrome (of the National Institute of Allergy and Infectious Diseases / National Institutes of Health) (DAIDS) Grading Scale and within normal reference ranges for other laboratory parameters not defined by DAIDS. Participation of subjects with abnormal laboratory values greater than Grade 1 (e.g., Creatine phosphokinase (CPK), amylase, triglycerides) is subject to approval by the Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) clinical monitor
• Age ≥18 and ≤60 years
• Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2
• Signed and dated written informed consent before admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation concerning volunteers who are capable of understanding and giving informed consent
• Willingness of subjects to abstain from ingesting the following foods and substances beginning 2 weeks before administration of any study medication and until the end of the study: grapefruit or grapefruit juice, red wine, Seville oranges, St. John's Wort and Milk Thistle
• Willingness of subjects to abstain from use of alcohol within 72 hours before administration of study medication and to the end of the study
• Willingness of subjects to abstain from the following substances within 72 hours before administration of study medication: garlic supplements and methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.)

You may not qualify if:

• Chronic gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy, cerebral cramps) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergies or hypersensitivity (including drug allergies) that are deemed relevant to the trial, as judged by the investigator
• Intake of drugs with a long half-life (\>24 hours) within 1 month or less than 10 half-lives of the drug before administration of study drug or during the trial
• Use of drugs that might reasonably influence the results of the trial (based on knowledge at the time of the protocol's preparation) within 10 days before administration of study drug or during the trial
• Participation in another trial with an investigational drug within 30 days before administration of study drug or during the trial.
• Smoker (more than 10 cigarettes per day, 3 cigars per day or 3 pipes per day)
• Inability to refrain from smoking 24 hours before receiving study medication and on trial days when pharmacokinetic (PK) data are collected
• High level of alcohol use (more than 60 grams per day)
• Illicit drug use (i.e., positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
• Veins unsuited for i.v. puncture on either arm (e.g., veins that are difficult to locate, access or puncture veins with a tendency to rupture during or after puncture)
• Blood donation (more than 100 mL within 4 weeks before administration of study medication or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Ritonavir

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 1, 2014
• Study Start: May 1, 2005
• Primary Completion: June 1, 2005
• Last Updated: October 1, 2014

Record last verified: 2014-09