Status and phase
Conditions
Treatments
About
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy adult human subjects.
Full description
Objective of this pivotal study was to assess the bioequivalence between Test Product: Metoprolol Succinate 200 mg Ipca Laboratories Limited, India and the corresponding Reference Product: TOPROL-XL® (Metoprolol Succinate) extended release Tablets 200 mg of Astrazenica LP, USA under fasting condition in healthy adult human subjects in a randomized crossover study.
The study was conducted with 48 healthy adult subjects. In each study period, a single 200 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.
The duration of the clinical phase was approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
18 to 45 years old, both inclusive.
Sex: Males and/or non-pregnant, non-lactating females.
BMI: 18.5 to 24.9 weight in kg/(height in meter)2 both inclusive;
Able to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent.
Able to give written informed consent to participate in the study.
All volunteers must be judged by the principal or co-investigator or physician as normal and healthy during a pre-study safety assessment performed within 21 days of the first dose of study medication which will include:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
48 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal