A Phase 1 interventional study of Doxycycline monohydrate and Monodox in To Determine Bioequivalence Under Fed Conditions, sponsored by Par Pharmaceutical, Inc.. Completed at 1 site in Canada. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-26.
Sponsored by Par Pharmaceutical, Inc. · Phase 1, Interventional, and Other
To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
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.
Exclusion Criteria:
Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fed conditions
Drug: Doxycycline monohydrate
Subjects received the reference product, Monodox (Oclassen) under fed conditions
Drug: Monodox
Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fasting conditions
Drug: Doxycycline Monohydrate
Capsules, 100 mg, fed
Also known as: Monodox
Capsules, 100 mg, fed
Also known as: Doxycycline Monohydrate
Capsules, 100 mg, fasting
Also known as: Monodox
Rate and extent of absorption
Time frame: 72 hours
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Par Pharmaceutical, Inc.