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

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.