Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions
Part of paid clinical trials in Fargo, North Dakota.
- Sponsor
- Roxane Laboratories
- Study ID
- NCT01132729
- Status
- Completed
Conditions
- Genital Herpes
- Herpes Zoster
- Shingles
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- Valacyclovir Hydrochloride — DRUG1000 mg caplet
Study Details
The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fasting conditions.
Key Dates
- Start date
- Sep 30, 2006
- Status verified
- Jan 2018
- Primary completion
- Sep 30, 2006
- Completion
- Sep 30, 2006
Study Design
- Enrollment
- 48 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Primary Outcome Measure
bioequivalence determined by statistical comparison Cmax [ Time Frame: 8 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| PRACs Institute, Ltd. | Fargo | North Dakota | 58104 | - |
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