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Phase 1 Completed N=30 Randomized Other

Venlafaxine 25 mg Tablets Under Fasting Conditions

Healthy
Source: ClinicalTrials.gov NCT00834964 ↗
Enrolled (actual)
30
Serious AEs
Results posted
Aug 2009
Primary outcomePrimary: Cmax - Maximum Observed Concentration - Venlafaxine in Plasma — 38.11; 39.91 ng/mL

Summary

The objective of this study is to compare the rate and extent of absorption of venlafaxine 25 mg tablets (test) versus Effexor® (reference) administered as 1 x 25 mg tablet under fasting conditions.

Outcome Measures

OutcomeResultp-value
PRIMARY
Cmax - Maximum Observed Concentration - Venlafaxine in Plasma
38.11; 39.91
PRIMARY
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Venlafaxine in Plasma
327.78; 309.75
PRIMARY
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Venlafaxine in Plasma
273.66; 273.03
SECONDARY
Cmax - O-Desmethylvenlafaxine in Plasma
60.01; 62.07
SECONDARY
AUC0-inf - O-Desmethylvenlafaxine in Plasma
1181.30; 1123.62
SECONDARY
AUC0-t - O-Desmethylvenlafaxine in Plasma
844.35; 838.37

Eligibility Criteria

Inclusion Criteria

  • Subjects will be females and/or males, non-smokers, 18 years of age and older. Female subjects will be post-menopausal or surgically sterilized.
  • Post-menopausal status is defined as absence of menses for the past 12 months or hysterectomy with bilateral oophorectomy at least 6 months ago.
  • Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.

Exclusion Criteria

  • Clinically significant illnesses within 4 weeks of the administration of study medication.
  • Clinically significant surgery within 4 weeks of the administration of study medication.
  • Any clinically significant abnormality found during medical screening.
  • Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
  • Abnormal laboratory tests judged clinically significant.
  • Positive urine drug screen at screening.
  • Positive testing for hepatitis B, hepatitis C, or HIV at screening.
  • ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90 mmHg; or heart rate less than 50 or over 100 bpm) at screening.
  • Subjects with BMI ≥ 30.0.
  • History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (1 Unit - 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
  • History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
  • History of allergic reactions to venlafaxine.
  • History of allergic reactions to heparin.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration of the study medication.
  • Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
  • History or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug.
  • Any history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
  • Positive alcohol breath test at screening.
  • Subjects who have used tobacco in any form within the 90 days preceding study drug administration.
  • Intolerance to venipuncture.
  • Subjects with a clinically significant history of tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma will not be eligible for this study.
  • Subjects who are unable to understand or unwilling to sign the Informed Consent Form.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical sub-investigator, contraindicates the subject's participation in this study.
  • Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.
  • Donation of plasma (500 mL) within 7 Days. Donation or loss of whole blood prior to administration of the study medication as fo
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00834964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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