TMC114-TiDP3-C176 - A Study in Healthy Volunteers Investigating the Bioequivalence Between Two Commercially Available 400-mg Tablets to One New 800-mg Tablet of Darunavir (DRV) in the Presence of Low-dose Ritonavir Under Fed and Fasted Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier:
NCT01308658
First received: February 3, 2011
Last updated: February 5, 2014
Last verified: February 2014

February 3, 2011
February 5, 2014
January 2011
Not Provided
  • Plasma concentrations of 100-mg ritonavir after a multiple oral dose on Days 1 to 5 in healthy volunteers in fed or fasted conditions [ Time Frame: measured on Day 1 to Day 6 ] [ Designated as safety issue: No ]
  • Plasma concentrations of Darunavir (DRV) after a single oral dose of 800-mg DRV on Day 3 in healthy volunteers in fed or fasted conditions [ Time Frame: measured on Day 1 ] [ Designated as safety issue: No ]
  • Plasma concentrations of DRV after a single oral dose of 800-mg DRV on Day 3 in healthy volunteers in fed or fasted conditions [ Time Frame: measured on Day 3 to Day 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01308658 on ClinicalTrials.gov Archive Site
  • Incidence of all adverse events by treatment group [ Time Frame: Measured from Day 1 until end of trial ] [ Designated as safety issue: Yes ]
  • Blood tests [ Time Frame: Measured from Day 1 until end of trial ] [ Designated as safety issue: Yes ]
  • Measurements of blood pressure [ Time Frame: Measured from Day 1 until end of trial ] [ Designated as safety issue: Yes ]
  • Measurements of pulse [ Time Frame: Measured from Day 1 until end of trial ] [ Designated as safety issue: Yes ]
  • Measurements of electrocardiograms [ Time Frame: Measured from Day 1 until end of trial ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
TMC114-TiDP3-C176 - A Study in Healthy Volunteers Investigating the Bioequivalence Between Two Commercially Available 400-mg Tablets to One New 800-mg Tablet of Darunavir (DRV) in the Presence of Low-dose Ritonavir Under Fed and Fasted Conditions
A Phase I, Open-label, Randomized, 2-panel, 2-way Crossover Pivotal Bioequivalence Trial Between the Commercially Available 400-mg Tablet Formulation (F030) and the 800-mg Tablet Formulation of Darunavir (G002), in the Presence of Low-dose Ritonavir Under Fasted and Fed Conditions

In this study participants will be given 800 mg darunavir, either as one 800-mg tablet formulation (G002), or as two commercially available 400-mg tablets formulation (F030), to evaluate the effect between both, in the presence of low-dose ritonavir under fasted and fed conditions.

Darunavir (DRV, formerly known as TMC114) is an inhibitor of human immunodeficiency virus (HIV) protease. This study is designed to establish the bioequivalence of a commercially available 400-mg tablet formulation (F030) to one 800-mg tablet formulation of DRV (G002) in the presence of low-dose ritonavir under fasted and fed conditions. This is a Phase I, open-label (both participant and investigator know the name of the medication given at certain moment), randomized (study medication is assigned by chance), 2-panel, 2-way crossover study in healthy volunteers to assess the bioequivalence of DRV following administration of 2 tablet strengths (in the presence of low-dose ritonavir) under fasted and fed conditions. A total of 124 participants will participate in this study. Participants will be divided into 2 panels; 80 participants in Panel 1 (fasted) and 44 in Panel 2 (fed). In Panel 1, during 2 subsequent sessions, each participant will receive 2 treatments under fasted conditions, meaning Treatment A, a single oral 800-mg dose of DRV formulated as the 400-mg commercially available tablet F030 and Treatment B, a single oral 800-mg dose of DRV formulated as the 800-mg tablet formulation G002. In Panel 2, the same design as Panel 1 will be followed but under fed conditions, and where the 2 treatments, respectively, will be called Treatments C and D. In both panels, participants will receive ritonavir 100 mg once a day on Days 1 to 5. Ritonavir will be administered under fed conditions in both panels except for the morning intake on Day 3 in Panel 2 where it will be administered under fasting conditions. A washout period of at least 7 days between subsequent treatments will be observed. Safety (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) and tolerability evaluations will be recorded at regular intervals throughout the trial. Panel 1 (fasted condition) and Panel 2 (fed condition): a single dose of 800 mg DRV on Day 3 and 100 mg ritonavir once daily from Day 1 to 5. DRV will be formulated as the commercially available 400-mg tablet formulation (F030) or as the investigational 800-mg tablet formulation (G002). Ritonavir will be used as the commercially available melt-extrusion tablet containing ritonavir eq. 100 mg.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Darunavir (DRV)
    2x400-mg DRV tablet or 800-mg tablet
  • Drug: ritonavir
    on Day 3
  • Experimental: 001
    Darunavir (DRV) 2x400-mg DRV tablet or 800-mg tablet on Day 3
    Intervention: Drug: Darunavir (DRV)
  • Experimental: 002
    ritonavir 100-mg once daily on Day 1 to Day 5
    Intervention: Drug: ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
May 2011
Not Provided

Inclusion Criteria:

  • Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram
  • Body Mass Index of 18.0 to 30.0 kg/m² and non-smoker or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months
  • Women must be postmenopausal for at least 2 years or be surgically sterile or be not heterosexually active for the duration of the study or have a vasectomized partner
  • Men must agree to use a highly effective method of birth control.

Exclusion Criteria:

  • Infection with Hepatitis A, B, or C virus
  • infection with HIV
  • Women who are pregnant or breastfeeding
  • History of, or any current medical condition which could impact the safety of the participant in the study
  • Previously participated in a multiple-dose study with DRV.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01308658
CR017776, TMC114-TiDP3-C176
Not Provided
Tibotec Pharmaceuticals, Ireland
Tibotec Pharmaceuticals, Ireland
Not Provided
Study Director: Tibotec Pharmaceuticals Clinical Trial Tibotec Pharmaceutical Limited
Tibotec Pharmaceuticals, Ireland
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP