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| Sponsor: | Mylan Pharmaceuticals |
|---|---|
| Information provided by: | Mylan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00649571 |
Purpose
The objective of this study was to investigate the bioequivalence of Mylan's doxycycline monohydrate 100 mg tablets to Par's Adoxa® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fasting conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Doxycycline Monohydrate Tablets (100 mg Drug: Adoxa Tablets 100 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Single-Dose Fasting In Vivo Bioequivalence Study of Doxycycline Monohydrate Tablets (100 mg; Mylan) and Adoxa Tablets (100 mg; Par) in Healthy Volunteers |
| Enrollment: | 35 |
| Study Start Date: | July 2005 |
| Study Completion Date: | July 2005 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Doxycycline Monohydrate Tablets 100 mg
|
Drug: Doxycycline Monohydrate Tablets (100 mg
100mg, single dose fasting
|
|
Active Comparator: 2
Adoxa Tablets 100 mg
|
Drug: Adoxa Tablets 100 mg
100mg, 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: | Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT00649571 History of Changes |
| Other Study ID Numbers: | DOXY-0536 |
| Study First Received: | March 30, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Doxycycline Doxycycline hyclate Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents |