Bioequivalence Study Doxycycline Tablets and Monodox Capsules Under Fasting Conditions

NCT00652795 | Completed Phase 1

• 1 other identifier: 40074
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).

Conditions

To Determine Bioequivalence Under Fasting Conditions

Keywords

bioequivalence; doxycycline monohydrate; fasting

Outcome Measures

Primary Outcomes (1)

• Rate and extent of absorption

  24 hours

Study Arms (2)

A

EXPERIMENTAL

Subjects received the Par product (Doxycycline Monohydrate) under fasting conditions.

Drug: Doxycycline Monohydrate

B

ACTIVE COMPARATOR

Subjects received the Oclassen's product (Monodox) Capsules under fasting conditions.

Drug: Monodox

Interventions

Doxycycline Monohydrate DRUG

Tablets, 150 mg, single-dose

Also known as: Monodox

A

Monodox DRUG

Capsules 50 mg (3 x 50 mg dose), single-dose

Also known as: Doxycycline Monohydrate

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-childbearing potential female, smoker or non-smokers
• years of age and older
• Non-childbearing potential female subjects is defined as post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy with bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration
• Capable of consent

You may not qualify if:

• Clinically significant illnesses within 4 weeks of the administration of study medication
• Clinically significant surgery within 4 weeks prior to the administration of the study medication
• Any clinically significant abnormality found during medical screening
• Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study
• Abnormal laboratory tests judged clinically significant
• Positive testing for hepatitis B, hepatitis C or HIV at screening
• ECG abnormalities or vital sign abnormalities at screening
• BMI greater than or equal to 30.0 kg/m2
• 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
• History of drug abuse or use of illegal drugs: soft drugs (marijuana) within 3 months prior to the screening visit or hard drugs (cocaine, PCP, crack) within 1 year prior to the screening visit or positive urine drug screen at screening
• History of allergic reactions to heparin, doxycycline, or other related drugs
• Use of any drugs known to induce or inhibit hepatic drug metabolism 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.
• Clinically significant history or presence of any clinically significant gastrointestinal pathology, unresolved gastrointestinal symptoms, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug
• Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• Anapharm: collaborator

Study Sites (1)

Anapharm

Sainte-Foy, Quebec, G1V 2K8, Canada

Location

MeSH Terms

Conditions

Fasting

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Benoit Girard, M.D.

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: July 1, 2004
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: April 4, 2008

Record last verified: 2008-04

Locations

CA (1)