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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00647959 |
Purpose
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 mg) dose administered under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Doxycycline Tablets, 150mg Drug: Adoxa Tablets 150 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
| Official Title: | Single-Dose Fasting Bioequivalence Study of Doxycycline Monohydrate Tablets (150 mg; Mylan) and Adoxa Tablets (150 mg; Par) in Healthy Volunteers |
| Enrollment: | 36 |
| Study Start Date: | March 2006 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Doxycycline Tablets, 150mg
|
Drug: Doxycycline Tablets, 150mg
150mg, single dose fasting
|
|
2: Active Comparator
Adoxa Tablets 150 mg
|
Drug: Adoxa Tablets 150 mg
150mg, single dose fasting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sex: Male and/or non-pregnant, non-lactating female.
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormone replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
Exclusion Criteria:
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
More Information
| Responsible Party: | Mylan Inc. ( Will Sullvan, Global Head of Product Risk and Safety Management ) |
| Study ID Numbers: | DOXY-0612 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00647959 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Antimalarials Anti-Infective Agents Anti-Bacterial Agents Antiparasitic Agents |
Antiprotozoal Agents Therapeutic Uses Pharmacologic Actions Doxycycline |