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Tetracycline Antibiotic
Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fasting Conditions
Phase 1
Waitlist Available
Led By Eric Masson, Pharm.D.
Research Sponsored by Par Pharmaceutical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group
Summary
The purpose of this study is to compare the single-dose bioequivalence of Par and Oclassen doxycycline monohydrate, 100 mg.
Eligible Conditions
- Bioequivalence
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2012 Phase 2 trial • 30 Patients • NCT0051187520%
neovascularization
13%
back pain (possibly with neck pain)
13%
headaches
13%
fall (cause of injuries unknown)
13%
high creatinine
13%
stomach virus
13%
chest cold
13%
pre-retinal hemorrhage
13%
vitreous hemorrhage
7%
fatigue
7%
anxiety (mild)
7%
sinus infection
7%
hypertension
7%
right ankle pain
7%
ocular hypertension right eye
7%
epiretinal fibrosis
7%
received dentures
7%
epidermoid cyst
7%
epiretinal membrane, (slight) right eye
7%
prostatitis
7%
right foot pain
7%
sleep apnea
7%
upper and lower teeth extracted
7%
upper respiratory infection
7%
nocturnal leg cramps
7%
vomiting
7%
fluid on left knee
7%
gout
7%
chalazion left eye
7%
increased glare
7%
pain in right shoulder
7%
nausea
7%
pulmonary embolism
7%
persistent vitreous hemorrhage
7%
umbilical hernia
7%
carpal tunnel surgery (left)
7%
dry rash
7%
constipation
7%
flu
7%
head cold
7%
cough
7%
neck stiffness
7%
leg pain (both)
7%
vitrectromy
7%
urinary retention
100%
80%
60%
40%
20%
0%
Study treatment Arm
Doxycycline Monohydrate
Placebo
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AExperimental Treatment1 Intervention
Subjects received the Par formulated product
Group II: BActive Control1 Intervention
Subjects received the Oclassen Pharmaceuticals formulated product.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxycycline
FDA approved
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Par Pharmaceutical, Inc.Lead Sponsor
35 Previous Clinical Trials
2,201 Total Patients Enrolled
AnapharmIndustry Sponsor
11 Previous Clinical Trials
385 Total Patients Enrolled
1 Trials studying Bioequivalence
28 Patients Enrolled for Bioequivalence
Eric Masson, Pharm.D.Principal InvestigatorAnapharm
7 Previous Clinical Trials
308 Total Patients Enrolled