Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fasting Conditions
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ClinicalTrials.gov Identifier: NCT00829764 |
Recruitment Status :
Completed
First Posted : January 27, 2009
Results First Posted : August 4, 2009
Last Update Posted : August 20, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Doxycycline Monohydrate | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
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 Start Date : | October 2006 |
Actual Primary Completion Date : | October 2006 |
Actual Study Completion Date : | October 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Doxycycline Monohydrate
|
Drug: Doxycycline Monohydrate
25 mg 5 mL dose |
Active Comparator: 2
Vibramycin Monohydrate®
|
Drug: Doxycycline Monohydrate
25 mg 5 mL dose
Other Name: Vibramycin Monohydrate® |
- Cmax = Maximum Observed Concentration. [ Time Frame: Blood samples collected over a 72 hour period. ]Bioequivalence based on Cmax.
- 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. ]Bioequivalence based on AUC0-t.
- AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity. [ Time Frame: Blood samples collected over a 72 hour period. ]Bioequivalence based on AUC0-inf.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829764
United States, Texas | |
CEDRA Clinical Research | |
San Antonio, Texas, United States, 78217 |
Principal Investigator: | James P Doherty, D.O. | CEDRA |
ClinicalTrials.gov Identifier: | NCT00829764 |
Other Study ID Numbers: |
20-064-SA |
First Posted: | January 27, 2009 Key Record Dates |
Results First Posted: | August 4, 2009 |
Last Update Posted: | August 20, 2009 |
Last Verified: | August 2009 |
Bioequivalence Healthy Subjects |
Doxycycline Anti-Bacterial Agents Anti-Infective Agents |
Antimalarials Antiprotozoal Agents Antiparasitic Agents |