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| Sponsor: | Par Pharmaceutical, Inc. |
|---|---|
| Collaborator: |
Anapharm |
| Information provided by: | Par Pharmaceutical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00652704 |
Purpose
To compare the rate and extent of absorption of doxycycline monohydrate capsules equivalent to 100 mg doxycycline (Par) versus Monodox (Oclassen Pharmaceuticals)
| Condition | Intervention | Phase |
|---|---|---|
|
To Determine Bioequivalence Under Fed Conditions. |
Drug: Doxycycline monohydrate Drug: Monodox Drug: Doxycycline Monohydrate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Randomized, Open-Label, 3-Way Crossover, Comparative Bioavailability Study of Par's and Oclassen's (Monodox) Doxycycline Monohydrate Capsules Administered as 1 x 100 mg Capsule in Healthy Adult Males Under Fasting and Fed Conditions |
| Enrollment: | 24 |
| Study Start Date: | July 1999 |
| Study Completion Date: | September 1999 |
| Primary Completion Date: | September 1999 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fed conditions
|
Drug: Doxycycline monohydrate
Capsules, 100 mg, fed
Other Name: Monodox
|
|
Active Comparator: B
Subjects received the reference product, Monodox (Oclassen) under fed conditions
|
Drug: Monodox
Capsules, 100 mg, fed
Other Name: Doxycycline Monohydrate
|
|
Experimental: C
Subjects received the test product, Doxycycline Monohydrate Capsules (Par) under fasting conditions
|
Drug: Doxycycline Monohydrate
Capsules, 100 mg, fasting
Other Name: Monodox
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Alfred Elvin/Director of Biopharmaceutics, Par Pharmaceutical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00652704 History of Changes |
| Other Study ID Numbers: | 99062 |
| Study First Received: | April 1, 2008 |
| Last Updated: | April 1, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Bioequivalence Doxycycline Monohydrate Fed |
|
Disease Pathologic Processes Doxycycline Doxycycline hyclate Anti-Bacterial Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents |