Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2013-04-30
2013-08-31
Brief Summary
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Detailed Description
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Subjects will be randomized to receive generic efavirenz 600 (Test formulation) or Stocrin(R) 600 tablets (Reference formulation)on study day 1 (period 1), then they will undergo a 24 hour intensive pharmacokinetic evaluation after ingesting a single dose of either the Test or Reference formulation. Additional pharmacokinetic samples 36, 48, 72, 120 and 192 hours postdose will be drawn.
Subjects will complete a wash out period form day 8 to day 28 during which no study drug will be ingested. On day 29 (period 2) they will ingest either the Test or the Reference formulation (opposite to the formulation received on period 1). All subjects undergo another 24 hour intensive pharmacokinetic evaluation and pharmacokinetics samples on days 36, 48, 72, 120, 192 pos-dose, respectively, will be drawn. Adverse events and concomitant medication will be documented throughout the study.
The sample size is 28 and is based on a 15% dropout rate (due to lost to follow-up, treatment discontinuation, etc.) Since the investigators are expecting four subjects not to complete the study,24 evaluable subjects are finally expected. If the discontinuation rate is greater than 15%, the investigators will continue to enroll until they get 24 evaluable subjects.
The primary endpoint is to determine average bioequivalence for Test and Reference formulation of efavirenz according to the FDA guidance on bioequivalence testing. The ratio of the Test to Reference formulation mean for efavirenz AUC0-192, AUC0-inf and Cmax and the 90% confidence interval around each mean ratio will be determined. Average bioequivalence will be met if 90% confidence interval around de AUC and Cmax mean ratios for efavirenz falls within the FDA's predefined limits of 0.80 to 1.25.
Safety will be evaluated by administering a questionnaire to the subjects during the study . This questionnaire will list the most frequent adverse effects already described for the innovator (Stocrin(R)). Safety will also be evaluated from vital signs recordings, lab tests out of the limits fixed in the study protocol and Psychiatric Evaluations during screening, in the wash out period and 15 days after the last administration of the study medication.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Efavirenz 600 Test-Stocrin 600 Reference
Efavirenz 600 mg will be randomly assigned.
Efavirenz 600 Test-Stocrin 600 Reference
Stocrin 600 Reference-Efavirenz 600 Test
Stocrin 600 mg will be randomly assigned.
Stocrin 600 Reference-Efavirenz 600 Test
Interventions
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Efavirenz 600 Test-Stocrin 600 Reference
Stocrin 600 Reference-Efavirenz 600 Test
Eligibility Criteria
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Inclusion Criteria
* Caucasians
* Age \>=18 and \<=50,
* BMI\>18 and BMI\<30 kg/m2
* HIV-1 negative, B Hepatitis negative, C Hepatitis negative.
* Able to give consent,
* Non/light-smoking,
* Lab screening and EKG within the limits stipulated in the protocol.
* Healthy as determine by medical examination.
Exclusion Criteria
* Subjects receiving any prescription or over-the-counter product.
* Subjects using any form of recreational drug.
* Subjects who has eaten grapefruit or drunk grapefruit juice during the last 15 days before administration of study drug.
* Subjects who had had xanthine containing beverages (mate, coffee, tea, chocolate, etc.) during 48 ours previous to study drug administration.
* Subjects with history of hepatic disease, renal disease, GI diseases, chronic infectious disease, heart disease, lung disease, neurologic disease, endocrine disease, etc.
* Subjects suffering any acute disease at screening or check-in.
* Alanine S. Transaminase(AST)/Alanine L. Transaminase(ALT) \> 3 times upper limit of normal (ULN).
* Bilirubin \> 2.5 times ULN.
* Amylase \> 2 times ULN.
* Absolute Neutrophil Count \<1000/mL.
* Hgb \< 9.0 g/dl.
* Platelets \> 50.000 cell/mm3,
* Serum Creatinine \> 2.5 mg/dl
18 Years
50 Years
MALE
Yes
Sponsors
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University of the Republic, Uruguay
OTHER
Center for Clinical Pharmacology Research Bdbeq S.A.
OTHER
Responsible Party
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Francisco E. Estevez-Carrizo, M.D.
Chief Medical Officer
Principal Investigators
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Francisco E. Estevez, M.D.
Role: PRINCIPAL_INVESTIGATOR
Center for Clinical Pharmacology Research Bdbeq S.A.
Locations
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Center for Cllinical Pharmacology Research-Bdbeq S.A.
Montevideo, Montevideo Department, Uruguay
Countries
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References
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Kaul S, Ji P, Lu M, Nguyen KL, Shangguan T, Grasela D. Bioavailability in healthy adults of efavirenz capsule contents mixed with a small amount of food. Am J Health Syst Pharm. 2010 Feb 1;67(3):217-22. doi: 10.2146/ajhp090327.
Mathias AA, Hinkle J, Menning M, Hui J, Kaul S, Kearney BP; Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen Development Team. Bioequivalence of efavirenz/emtricitabine/tenofovir disoproxil fumarate single-tablet regimen. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):167-73. doi: 10.1097/QAI.0b013e3181427835.
Frampton JE, Croom KF. Efavirenz/emtricitabine/tenofovir disoproxil fumarate: triple combination tablet. Drugs. 2006;66(11):1501-12; discussion 1513-4. doi: 10.2165/00003495-200666110-00012.
Marier JF, Morin I, Al-Numani D, Stiles M, Morelli G, Tippabhotla SK, Vijan T, Singla AK, Garg M, Di Marco M, Monif T. Comparative bioavailability of a generic capsule formulation of the reverse transcriptase inhibitor efavirenz and the innovator product. Int J Clin Pharmacol Ther. 2006 Apr;44(4):180-4. doi: 10.5414/cpp44180.
Other Identifiers
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bdbeq-efv600/icuvita-020
Identifier Type: -
Identifier Source: org_study_id