|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Par Pharmaceutical, Inc. |
|---|---|
| Collaborator: |
Anapharm |
| Information provided by: | Par Pharmaceutical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00652795 |
Purpose
To compare the rate and extent of absorption of doxycycline tablet (Par) versus doxycycline capsule (Monodox)(Oclassen).
| Condition | Intervention | Phase |
|---|---|---|
|
To Determine Bioequivalence Under Fasting Conditions |
Drug: Doxycycline Monohydrate Drug: Monodox |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Randomized, 2-Way Crossover, Bioequivalence Study of Doxycycline 150 mg Tablet and Monodox 50 mg Capsule Administered as 1 x 150 mg Tablet or 3 x 50 mg Capsules in Healthy Subjects Under Fasting Conditions |
| Enrollment: | 36 |
| Study Start Date: | July 2004 |
| Study Completion Date: | September 2004 |
| Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Subjects received the Par product (Doxycycline Monohydrate) under fasting conditions.
|
Drug: Doxycycline Monohydrate
Tablets, 150 mg, single-dose
Other Name: Monodox
|
|
Active Comparator: B
Subjects received the Oclassen's product (Monodox) Capsules under fasting conditions.
|
Drug: Monodox
Capsules 50 mg (3 x 50 mg dose), single-dose
Other Name: Doxycycline Monohydrate
|
To compare the rate and extent of absorption of doxycycline 150 mg tablet (test) versus Monodox 50 mg capsule (reference) administered as 1 x 50 mg tablet or 3 x 50 mg capsules under fasting conditions.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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: | NCT00652795 History of Changes |
| Other Study ID Numbers: | 40074 |
| Study First Received: | April 1, 2008 |
| Last Updated: | April 1, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
bioequivalence doxycycline monohydrate fasting |
|
Disease Pathologic Processes Doxycycline Doxycycline hyclate Anti-Bacterial Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents |