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Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00829790
First received: January 26, 2009
Last updated: August 14, 2009
Last verified: August 2009

January 26, 2009
August 14, 2009
October 2006
October 2006   (final data collection date for primary outcome measure)
  • Cmax = Maximum Observed Concentration. [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
  • AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration. [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
  • AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity. [ Time Frame: Blood samples collected over a 72 hour period. ] [ Designated as safety issue: No ]
Bioequivalence based on Cmax and AUC [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00829790 on ClinicalTrials.gov Archive Site
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Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fed Conditions
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Study of Doxycycline Monohydrate 25 mg as a 5mL Oral Suspension Under Fed Conditions

The objective of this study was to compare the rate of absorption and the oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension manufactured by IVAX Pharmaceuticals, Inc. and distributed by TEVA Pharmaceuticals USA to an equivalent oral dose of the commercially available reference product, Vibramycin Monohydrate® manufactured by Pfizer, Inc. Following an overnight fast of at least 10 hours, subjects consumed a standard high-calorie. high-fat breakfast meal. This standard breakfast meal began 30 minutes prior to each dose.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Doxycycline Monohydrate
    25 mg 5mL oral dose
  • Drug: Doxycycline Monohydrate
    25 mg 5 mL dose
    Other Name: Vibramycin Monohydrate®
  • Experimental: 1
    Doxycycline Monohydrate
    Intervention: Drug: Doxycycline Monohydrate
  • Active Comparator: 2
    Vibramycin Monohydrate®
    Intervention: Drug: Doxycycline Monohydrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2006
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria

All subjects must satisfy the following criteria to be considered for study participation:

  • Subject must be male or non-pregnant, non-breast-feeding female
  • Subject must be at least 18 years of age
  • Subject must have a Body Mass Index (BMI) between 18 and 30 kg/m2, inclusive, and body weight should be at least 50 kg (110 lbs)
  • Female Subjects - not surgically sterile or at least two years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, double barrier (condom with spermicide, diaphragm with spermicide), intra-uterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).
  • Subject must voluntarily consent to participate in this study and provide their written informed consent prior to the start of any study-specific procedures.
  • Subject is willing and able to consume the entire high-calorie, high-fat breakfast meal in the designated timeframe required during each study period.
  • Subject is willing and able to remain in the study unit for the entire duration of each confinement period and return for any outpatient visits.

Exclusion Criteria

Subjects may be excluded for any of the following:

  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
  • Has a clinically significant abnormal finding on the physical exam, medical history, ECG or clinical laboratory results at screening.
  • History or presence of allergic or adverse response to doxycycline monohydrate or related drugs.
  • Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.
  • Has donated blood or plasma within 30 days prior to the first dose of study medication.
  • Has participated in another clinical trial within 30 days prior to the first dose of study medication.
  • Has used any over-the-counter (OTC) medication, including nutritional supplements, within 7 days prior to the first dose of study medication.
  • Has used any prescription medication, including hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
  • Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
  • Has smoked or used tobacco products within 90 days prior to the first dose of study medication.
  • Is a female with a positive pregnancy test result.
  • Has an intolerance to venipuncture.
  • Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates)
  • Has a history of drug or alcohol abuse.
  • Has had a positive test for, or has been treated for hepatitis B, hepatitis C or HIV.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829790
20-065-SA
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Teva Pharmaceuticals USA
Not Provided
Principal Investigator: Frederick A Bieberdorf, M.D. CEDRA Clinical Research
Teva Pharmaceuticals USA
August 2009

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