Drug - Drug Interaction Study Between Quinine Sulfate and Theophylline

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

September 30, 2007

Study Completion Date

September 30, 2007

Conditions
Pharmacokinetics
Interventions
DRUG

Theophylline 300mg

Single doses of theophylline 300 mg as an immediate-release oral solution 80mg/15ml concentration administered alone at 7 am on Day 1 after an overnight fast of at least 10 hours and along with quinine sulfate (2 x 324 mg capsules) at 7am on Day 12 after an overnight fast of at least 10 hours.

DRUG

Quinine 648 mg

648 mg quinine sulfate(2 x 324 mg capsules) initiated at 3pm on Day 5 and taken every 8 hours through Day 11 and co-administered with theophylline 300 mg as an immediate-release oral solution 80 mg/15 ml concentration at 7am on Day 12.

DRUG

Theophylline 300 mg

Single doses of theophylline 300 mg as an immediate-release oral solution 80mg/15ml concentration administered alone at 7 am on Day 1 after an overnight fast of at least 10 hours and along with quinine sulfate (2 x 324 mg capsules) at 7am on Day 12 after an overnight fast of at least 10 hours.

DRUG

Quinine 648 mg

648 mg quinine sulfate(2 x 324 mg capsules) initiated at 3pm on Day 5 and taken every 8 hours through Day 11 and co-administered with theophylline 300 mg as an immediate-release oral solution 80 mg/15 ml concentration at 7am on Day 12.

Trial Locations (1)

58104

PRACS Institute, Fargo

All Listed Sponsors
lead

Mutual Pharmaceutical Company, Inc.

INDUSTRY

NCT00779259 - Drug - Drug Interaction Study Between Quinine Sulfate and Theophylline | Biotech Hunter | Biotech Hunter