Trials / Unknown
UnknownNCT05794919
Bioequivalence Study of Calcium Hydroxybenzene Sulphonate Dispersible Tablets in Chinese Healthy Volunteers
Bioequivalence Study of Calcium Hydroxybenzene Sulphonate Dispersible Tablets and Calcium Hydroxybenzene Sulfonate Tablets (Doxium®) Under Fed Conditions in Chinese Healthy Volunteers
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- Beijing Tongren Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study is to evaluate the bioequivalence of two Calcium Hydroxybenzene Dispersible Tablets in healthy Chinese volunteers.
Detailed description
The trial preparation is Calcium Hydroxybenzene Sulphonate Dispersible Tablets produced by Hainan Linheng Pharmaceutical Co., Ltd. The reference preparation is Calcium Hydroxybenzene Sulphonate Tablets (Doxium ®) produced by OM pharma S.A. The bioequivalence of two preparations will be evaluated at the fast or fed conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g | A generic product manufactured by Hainan Linheng Pharmaceutical Co., Ltd. |
| DRUG | Calcium Hydroxybenzene Sulfonate Tablets（Doxium®) 250mg | Calcium Hydroxybenzene Sulfonate Tablets（Doxium®）produced by OM pharma S.A. |
Timeline
- Start date
- 2023-03-20
- Primary completion
- 2023-04-01
- Completion
- 2023-12-01
- First posted
- 2023-04-03
- Last updated
- 2023-04-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05794919. Inclusion in this directory is not an endorsement.