Trials / Unknown
UnknownNCT03232710
Bioequivalence Study of Bosiqing and ABILIFY Under Fasting/Fed Condition
A Single-dose, Two-treatment, Two-sequence, Two-period, Two Way Crossover Bioequivalence Study of Bosiqing Aripiprazole Orally Disintegrating Tablets and ABILIFY Under Fasting/Fed Condition
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- Sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 45 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
To compare the rate and extent of absorption of Aripiprazole Orally disintegrating tablets 10 mg of Chengdu Kanghong Pharmaceutical Group Co.,Ltd, China and ABILIFY (Aripiprazole) 10 mg orodispersible tablets of Otsuka Pharmaceutical Europe Ltd. in healthy, adult, human subjects under fasting/fed condition as well as to monitor the safety and tolerability of subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bosiqing | Aripiprazole Orally disintegrating tablets 10mg |
| DRUG | abilify | Aripiprazol orodispersible tablets 10mg |
Timeline
- Start date
- 2017-06-26
- Primary completion
- 2018-04-30
- Completion
- 2018-06-30
- First posted
- 2017-07-28
- Last updated
- 2017-07-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03232710. Inclusion in this directory is not an endorsement.