Clinical trial NCT00829764: Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fasting Conditions
Official title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Study of Doxycycline Monohydrate 25 mg as a 5 mL Oral Suspension Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Healthy Subjects
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2009-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and 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.

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax = Maximum Observed Concentration.
timeFrame: Blood samples collected over a 72 hour period.
measure: AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.
timeFrame: Blood samples collected over a 72 hour period.
measure: AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
timeFrame: Blood samples collected over a 72 hour period.
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: CEDRA Clinical Research
state: Texas
Study officials:
affiliation: CEDRA
name: James P Doherty, D.O.
role: PRINCIPAL_INVESTIGATOR
References: