Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04798222
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2021-03-11
Brief Title:
Study to Assess the Bioavailability of Different Formulations of AZD9977 and Dapagliflozin and Influence of Food in Selected Formulations in Healthy Volunteers
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
An Open-label Randomized Parallel Group FourFive Period Eight Treatment Cross-over Single Oral Dose Study to Assess the Relative Bioavailability of Different Formulations of AZD9977 and Dapagliflozin and Influence of Food in Selected Formulations in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of the study is to evaluate relative bioavailability of AZD9977 and dapagliflozin and compare the plasma concentration time profiles after dosing with different capsule formulations containing both AZD9977 and dapagliflozin or solely dapagliflozin the AZD9977 capsule and dapagliflozin tablet under fasted conditions
Detailed Description:
The study will be conducted at 2 study centers in Germany
Eligible participants will be randomized to one of the 8 treatment sequences 4 unique sequences to Group 1 and 4 unique sequences to Group 2 In Group 1 participants will receive 5 single dose treatments while in Group 2 participants will receive 4 single dose treatments
Below treatments A B C D and E will be given to participants in Group 1 and treatments A F G and H will be given to participants in Group 2 in randomized order
1 Treatment A AZD9977 Dose A 10 mg dapagliflozin tablet fasted
2 Treatment B AZD9977 Dose A 10 mg dapagliflozin capsule 1 fasted
3 Treatment C AZD9977 Dose A 10 mg dapagliflozin capsule 1 fed
4 Treatment D AZD9977 Dose A 10 mg dapagliflozin capsule 2 fasted
5 Treatment E AZD9977 Dose A 10 mg dapagliflozin capsule 2 fed
6 Treatment F AZD9977 Dose A 10 mg dapagliflozin capsule 3 fasted
7 Treatment G AZD9977 Dose A 10 mg dapagliflozin capsule 4 fasted
8 Treatment H 10 mg dapagliflozin capsule fasted
The study will comprise of the following
A screening period of maximum 21 days
Four or five treatment periods during which participants will be resident at the study center from the day before dosing until at least 72 hours after the final dose
A final visit within 5 to 7 days after administration of the last treatment
Each participant will receive single dose treatments under fasted or fed conditions separated by at least 4 days washout
Each participant will be involved in the study for approximately 6 to 7 weeks
Eligible participants will be randomized to one of the 8 treatment sequences 4 unique sequences to Group 1 and 4 unique sequences to Group 2 In Group 1 participants will receive 5 single dose treatments while in Group 2 participants will receive 4 single dose treatments
Below treatments A B C D and E will be given to participants in Group 1 and treatments A F G and H will be given to participants in Group 2 in randomized order
1 Treatment A AZD9977 Dose A 10 mg dapagliflozin tablet fasted
2 Treatment B AZD9977 Dose A 10 mg dapagliflozin capsule 1 fasted
3 Treatment C AZD9977 Dose A 10 mg dapagliflozin capsule 1 fed
4 Treatment D AZD9977 Dose A 10 mg dapagliflozin capsule 2 fasted
5 Treatment E AZD9977 Dose A 10 mg dapagliflozin capsule 2 fed
6 Treatment F AZD9977 Dose A 10 mg dapagliflozin capsule 3 fasted
7 Treatment G AZD9977 Dose A 10 mg dapagliflozin capsule 4 fasted
8 Treatment H 10 mg dapagliflozin capsule fasted
The study will comprise of the following
A screening period of maximum 21 days
Four or five treatment periods during which participants will be resident at the study center from the day before dosing until at least 72 hours after the final dose
A final visit within 5 to 7 days after administration of the last treatment
Each participant will receive single dose treatments under fasted or fed conditions separated by at least 4 days washout
Each participant will be involved in the study for approximately 6 to 7 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-000483-30 | EUDRACT_NUMBER | None | None |