Herpes Zoster Clinical Trial
Official title:
A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Valacyclovir Caplets Under Fed Conditions
| Verified date | January 2018 |
| Source | West-Ward Pharmaceutical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fed conditions.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | September 2006 |
| Est. primary completion date | September 2006 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: - Positive test for HIV, Hepatitis B, or Hepatitis C. - Treatment with known enzyme altering drugs. - History of allergic or adverse response to valacyclovir hydrochloride or any comparable or similar product. |
| Country | Name | City | State |
|---|---|---|---|
| United States | PRACs Institute, Ltd. | Fargo | North Dakota |
| Lead Sponsor | Collaborator |
|---|---|
| Roxane Laboratories |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | bioequivalence determined by statistical comparison Cmax | 8 days |
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