Advertisement
Advertise here Publish your press releases here Sponsor BioPortfolio
Follow us on Twitter Sign up for daily news and research emails Contributors wanted

Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions

17:37 EDT 17th April 2014 | BioPortfolio

Summary

To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)

Description

To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline by Par Pharmaceutical Inc., USA (test) versus Monodox by Oclassen Pharmaceuticals, Inc., USA (reference) administered as a 1 x 100 mg capsule under fasting and fed conditions.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

To Determine Bioequivalence Under Fed Conditions.

Intervention

Doxycycline monohydrate, Monodox, Doxycycline Monohydrate

Location

Anapharm, Inc.
Sainte-Foy
Quebec
Canada
G1V 2K8

Status

Completed

Source

Par Pharmaceutical, Inc.

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

A synthetic TETRACYCLINE derivative with similar antimicrobial activity. Animal studies suggest that it may cause less tooth staining than other tetracyclines. It is used in some areas for the treatment of chloroquine-resistant falciparum malaria (MALARIA, FALCIPARUM).

Adhesives used to fix prosthetic devices to bones and to cement bone to bone in difficult fractures. Synthetic resins are commonly used as cements. A mixture of monocalcium phosphate, monohydrate, alpha-tricalcium phosphate, and calcium carbonate with a sodium phosphate solution is also a useful bone paste.

Measurement or recording of contraction activity of the uterine muscle. It is used to determine progress of LABOR, OBSTETRIC and assess status of pregnancy. It is also used in conjunction with FETAL MONITORING to determine fetal response to stress of maternal uterine contractions.

Studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries.

Testing erythrocytes to determine presence or absence of blood-group antigens, testing of serum to determine the presence or absence of antibodies to these antigens, and selecting biocompatible blood by crossmatching samples from the donor against samples from the recipient. Crossmatching is performed prior to transfusion.

Clinical Trials [261 Associated Clinical Trials listed on BioPortfolio]

Bioequivaelnce Study of Doxycycline Monohydrate 100mg Tablets Under Fed Conditions

The purpose of this study was to determine the bioequivalence of Doxycycline monohydrate formulations after administration of single doses to normal healthy subjects under fed conditions....

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

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 mo...

Fasting Study of Doxycycline Monohydrate Tablets 150 mg and Adoxa Tablets 150 mg

The objective of this study was to investigate the bioequivalence of Mylan's doxycycline monohydrate 150 mg tablets to Par's Adoxa® 150 mg tablets following a single, oral 150 mg (1 x 150...

Bioequivalence Between Two Tablet Formulations Of Doxycycline Carragenate

The purpose of this protocol is to study if two different tablet formulations of doxycycline are bioequivalent to each other.

Evaluation of Effect of Doxycycline Verses Placebo on Retinal Function and Diabetic Retinopathy

This 24 month randomized research study will evaluate whether doxycycline can slow the deterioration or improve retinal function among patients with mild to moderate non-proliferative diab...

PubMed Articles [4957 Associated PubMed Articles listed on BioPortfolio]

Doxycycline and suicidality.

A case series outlining three young individuals with no history of mental disorder who were treated for skin conditions with doxycycline, but developed suicidal ideation with an outcome of suicide in...

Retarded low-dose doxycycline for EGFR or MEK inhibitor-induced papulopustular rash.

Epidermal growth factor receptor inhibitors (EGFRi) and MEK inhibitors (MEKi) are notorious for causing papulopustular rash. Treatment recommendations from studies and expert panels include, amongst o...

Pharmaceutical hydrates under ambient conditions from high-pressure seeds: a case study of GABA monohydrate.

The monohydrate form of the neurotransmitter γ-amino butyric acid (GABA) has been crystallised in the 0.4-0.8 GPa pressure range, recovered to ambient pressure and then used as a seed. Theoretical ca...

The effect of prolonged systemic doxycycline therapy on serum tissue degrading proteinases in coronary bypass patients: a randomized, double-masked, placebo-controlled clinical trial.

Serum matrix metalloproteinases (MMP-8, MMP-7) and their regulators may be associated with the risk of incident cardiovascular disease events. Doxycycline can be used as matrix metalloproteinase (MMP)...

Doxycycline for stabilization of abdominal aortic aneurysms: a randomized trial.

Doxycycline inhibits formation and progression of abdominal aortic aneurysms (AAAs) in preclinical models of the disease, but it is unclear whether and how this observation translates to humans.

More From BioPortfolio on "Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions"

Search BioPortfolio:
Advertisement
Advertisement